GE Healthcare, CARESCAPE Monitor B650. A multi-parameter patient monitor intended for use in mult...
FDA Device Recall #Z-2114-2014 — Class II — July 7, 2014
Recall Summary
| Recall Number | Z-2114-2014 |
| Classification | Class II — Moderate risk |
| Date Initiated | July 7, 2014 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | GE Healthcare, LLC |
| Location | Waukesha, WI |
| Product Type | Devices |
| Quantity | 21,799 (7,635 units US, 14,164 units OUS) |
Product Description
GE Healthcare, CARESCAPE Monitor B650. A multi-parameter patient monitor intended for use in multiple areas and intrahospital transport within a professional healthcare facility.
Reason for Recall
Possible sound loss associated with the CARESCAPE Monitor B650. When an external display is connected to the CARESCAPE Monitor B650 using a USB extender cable with an active USB hub, the system may experience a sound loss including alarm sounds from the patient monitor. This may occur if the external display is powered off and on during normal operation of the monitor.
Distribution Pattern
Worldwide distribution. US nationwide including Puerto Rico, ZAMBIA, YEMEN, VIETNAM, VENEZUELA, URUGUAY, UNITED KINGDOM, UNITED ARAB EMIRATES, TURKEY, THAILAND, UNITED REPUBLIC OF TANZANIA, TAJIKISTAN, TAIWAN, SYRIA, SWITZERLAND, SWEDEN, SRILANKA, SPAIN, SOUTH AFRICA, SLOVENIA, SLOVAKIA, SINGAPORE, SAUDI ARABIA, RUSSIAN F¿D¿RATION, ROMANIA, QATAR, PORTUGAL, POLAND, PHILIPPINES, PERU, PARAGUAY, PANAMA, PAKISTAN, OMAN, NORWAY, NICARAGUA, NEW ZEALAND, NETHERLAND, NAMIBIA, MYANMAR, MOROCCO, MEXICO, MAURITIUS, MALAYSIA, LITHUANIA, LIBYAN ARAB JAMAHIRIYA, LEBANON, LATVIA, KUWAIT, REPUBLIC OF KOREA, KAZAKHSTAN, JORDAN, Italy, JAPAN, JAMAICA, ISRAEL, IRELAND, IRAQ, INDONESIA, INDIA, ICELAND, HUNGARY, HONG KONG, HONDURAS, GUATEMALA, GREECE, GERMANY, GEORGIA, FRANCE, FINLAND, ESTONIA, EL SALVADOR, Egypt, ECUADOR, DENMARK, CZECH REPUBLIC, CYPRUS, CROATIA, COSTA RICA, COLOMBIA, CHINA, CHILE, CANADA, BULGARIA, BRUNEI, BRAZIL, BOLIVIA, BERMUDA, BELGIUM, BANGLADESH, BAHRAIN, BAHAMAS, AZERBAIJAN, AUSTRIA, AUSTRALIA, ARGENTINA.
Lot / Code Information
Mfg Lot or Serial # System ID SEW10233202HA M1176021-052037 SEW10233203HA M1176021 SEW10233204HA M1176021-052037 SEW10233206HA M1176021-052037 SEW10233209HA M1176021-052037 SEW10233210HA M1176021-052037 SEW10243447HA M1176021-052037 SEW10243449HA M1176021-052037 SEW10243450HA M1176021-052037 SEW10243458HA M1176021-052037 SEW10243476HA M1176021-052037 SEW10243477HA M1176021-052037 SEW10243478HA M1176021-052037 SEW10243479HA M1176021-052037 SEW10243481HA M1176021-052037 SEW10243482HA M1176021-052037 SEW10243484HA M1176021-052037 SEW10243486HA M1176021-052037 SEW10243487HA M1176021-052037 SEW10243489HA M1176021-052037 SEW10243490HA M1176021-052037 SEW10243491HA M1176021-052037 SEW10243492HA M1176021-052037 SEW10243496HA M1176021-052037 SEW10243499HA M1176021-052037 SEW10243500HA M1176021-052037 SEW10243503HA M1176021-052037 SEW10243504HA M1176021-052037 SEW10354687HA M1176021 SEW10354688HA M1176021 SEW10354694HA M1176021-052037 SEW10354695HA M1176021-052037 SEW10354696HA M1176021-052037 SEW10354697HA M1176021-052037 SEW10354701HA M1176021-052037 SEW10354704HA M1176021 SEW10354706HA M1176021-052037 SEW10354707HA M1176021-052037 SEW10354708HA M1176021-052037 SEW10354709HA M1176021-052037 SEW10354712HA M1176021-052037 SEW10354713HA M1176021-052037 SEW10354717HA M1176021 SEW10354722HA M1176021-052037 SEW10354724HA M1176021-052037 SEW10354728HA M1176021-052037 SEW10354730HA M1176021-052037 SEW10354736HA M1176021-052037 SEW10354738HA M1176021 SEW10354740HA M1176021-052037 SEW10354741HA M1176021-052037 SEW10354746HA M1176021-052037 SEW10354749HA M1176021-052037 SEW10354751HA M1176021-052037 SEW10354752HA M1176021-052037 SEW10354754HA M1176021-052037 SEW10354756HA M1176021-052037 SEW10354757HA M1176021-052037 SEW10354758HA M1176021-052037 SEW10354759HA M1176021-052037 SEW10354760HA M1176021-052037 SEW10354761HA M1176021-052037 SEW10354762HA M1176021-052037 SEW10354763HA M1176021-052037 SEW10354764HA M1176021-052037 SEW10354767HA M1176021-052037 SEW10354768HA M1176021-052037 SEW10354773HA M1176021-052037 SEW10354774HA M1176021-052037 SEW10354775HA M1176021-052037 SEW10354776HA M1176021-052037 SEW10354777HA M1176021-052037 SEW10354778HA M1176021-052037 SEW10354780HA M1176021-052037 SEW10354781HA M1176021-052037 SEW10354783HA M1176021-052037 SEW10354784HA M1176021-052037 SEW10385221HA M1176021-052037 SEW10385223HA M1176021 SEW10385225HA M1176021 SEW10385226HA M1176021 SEW10385227HA M1176021 SEW10385228HA M1176021 SEW10385230HA M1176021-052037 SEW10385231HA M1176021-052037 SEW10385232HA M1176021-052037 SEW10385234HA M1176021-052037 SEW10385236HA M1176021 SEW10385256HA M1176021-052037 SEW10393672HA M1176021-062897 SEW10393675HA M1176021-062897 SEW10393682HA M1176021-062897 SEW10393747HA M1176021-079419 SEW10405542HA M1176021-069222 SEW10405618HA M1176021-079419 SEW10405648HA M1205643-088364 SEW10405669HA M1176021-062897 SEW10405670HA M1176021-062897 SEW10405673HA M1176021-062897 SEW10405696HA M1176021-062897 SEW10446451HA M1176021-079419 SEW10446466HA M1205643-101584 SEW10456855HA M1176021-103880 SEW10467083HA M1205643-088364 SEW10467133HA M1176021-062897 SEW10467151HA M1176021-062897 SEW10467216HA M1176021-062897 SEW10467289HA M1176021-103880 SEW10517983HA M1176021-067875 SEW10528081HA M1176021-067875 SEW10528111HA M1176021-067875 SEW11018531HA M1176021-067875 SEW11018538HA M1176021-067875 SEW11018545HA M1176021-067875 SEW11018644HA M1176021-067875 SEW11018645HA M1176021-067875 SEW11018646HA M1176021-067875 SEW11018647HA M1176021-067875 SEW11018650HA M1176021-067875 SEW11018651HA M1176021-067875 SEW11018652HA M1176021-067875 SEW11018653HA M1176021-067875 SEW11018702HA M1176021-067875 SEW11018721HA M1176021-067875 SEW11018725HA M1176021-067875 SEW11018729HA M1176021-067875 SEW11018730HA M1176021-067875 SEW11018731HA M1176021-067875 SEW11018732HA M1176021-067875 SEW11038851HA M1176021-067875 SEW11038910HA M1176021-078234 SEW11038918HA M1176021-067875 SEW11059070HA M1205643-088364 SEW11059082HA M1205643-088364 SEW11059083HA M1205643-088364 SEW11059084HA M1205643-088364 SEW11059128HA M1176021-067875 SEW11059129HA M1176021-067875 SEW11059130HA M1176021-067875 SEW11059131HA M1176021-067875 SEW11059132HA M1176021-067875 SEW11059133HA M1176021-067875 SEW11059134HA M1176021-067875 SEW11059135HA M1176021-067875 SEW11059136HA M1176021-067875 SEW11059137HA M1176021-067875 SEW11059138HA M1176021-080617 SEW11059139HA M1176021-085419 SEW11059140HA M1176021-085419 SEW11059141HA M1176021-085419 SEW11059142HA M1176021-052037 SEW11059143HA M1176021-085419 SEW11059144HA M1176021-085419 SEW11059145HA M1176021-077889 SEW11059148HA M1176021-052037 SEW11059149HA M1176021-078234 SEW11059150HA M1176021-052037 SEW11059151HA M1176021-062617 SEW11059153HA M1176021-052037 SEW11059155HA M1176021-062617 SEW11059156HA M1176021-062617 SEW11059157HA M1176021-052037 SEW11059158HA M1176021-052037 SEW11059159HA M1176021-052037 SEW11059160HA M1176021-052037 SEW11059161HA M1176021-052037 SEW11059164HA M1176021-052037 SEW11059165HA M1176021-052037 SEW11059166HA M1176021-062617 SEW11059168HA M1176021-052037 SEW11059169HA M1176021-052037 SEW11059171HA M1176021-052037 SEW11059172HA M1176021-071488 SEW11059173HA M1176021-052037 SEW11059174HA M1176021-052037 SEW11059175HA M1176021-052037 SEW11059177HA M1176021-062617 SEW11059178HA M1176021-062617 SEW11059179HA M1176021-069587 SEW11059180HA M1176021-062617 SEW11059181HA M1176021-062617 SEW11059182HA M1176021-062617 SEW11059183HA M1176021-062617 SEW11059184HA M1176021-052037 SEW11059185HA M1176021-062617 SEW11059186HA M1176021-062617 SEW11059187HA M1176021-071108 SEW11059188HA M1176021-052037 SEW11059189HA M1176021-052037 SEW11059190HA M1176021-062617 SEW11059191HA M1176021-052037 SEW11059192HA M1176021-052037 SEW11059193HA M1176021-052037 SEW11059194HA M1176021-052037 SEW11059198HA M1176021-071108 SEW11059200HA M1176021-069587 SEW11059202HA M1176021-071108 SEW11059204HA M1176021-077172 SEW11059206HA M1176021-071108 SEW11059208HA M1176021-069586 SEW11059212HA M1176021-077889 SEW11059213HA M1176021-068615 SEW11059215HA M1176021-077889 SEW11059216HA M1176021-071108 SEW11059217HA M1176021-085262 SEW11059218HA M1176021-085684 SEW11059219HA M1176021-077889 SEW11059220HA M1176021-071108 SEW11059221HA M1176021-062617 SEW11059226HA M1176021-077889 SEW11059227HA M1176021-077889 SEW11059233HA M1176021-077889 SEW11059234HA M1176021-085684 SEW11059235HA M1176021-068615 SEW11059236HA M1176021-069586 SEW11059242HA M1176021-069587 SEW11059243HA M1176021-075931 SEW11079351HA M1176021-069587 SEW11079352HA M1176021-062617 SEW11079353HA M1176021-073046 SEW11079354HA M1176021-062617 SEW11079355HA M1176021-085684 SEW11079357HA M1176021-066211 SEW11079358HA M1176021-062617 SEW11079359HA M1176021-062617 SEW11079360HA M1176021-052037 SEW11079361HA M1176021-062617 SEW11079363HA M1176021-069587 SEW11079365HA M1176021-068615 SEW11079366HA M1176021-071488 SEW11079367HA M1176021-085684 SEW11079368HA M1176021-071488 SEW11079369HA M1176021-052037 SEW11079370HA M1176021-052037 SEW11079371HA M1176021-068615 SEW11079372HA M1176021-052037 SEW11079373HA M1176021-077172 SEW11079375HA M1176021-068615 SEW11079376HA M1176021-052037 SEW11079377HA M1176021-077889 SEW11079378HA M1176021-077172 SEW11079379HA M1176021-085684 SEW11079380HA M1176021-085684 SEW11079381HA M1176021-077889 SEW11079382HA M1176021-068615 SEW11079383HA M1176021-085684 SEW11079384HA M1176021-068615 SEW11079387HA M1176021-066795 SEW11079392HA M1176021-069587 SEW11079394HA M1176021-073046 SEW11079396HA M1176021-077889 SEW11079408HA M1176021-066795 SEW11079415HA M1176021-069587 SEW11079417HA M1176021-069587 SEW11079418HA M1176021-069587 SEW11079419HA M1176021-077172 SEW11079420HA M1176021-066211 SEW11079421HA M1176021-069587 SEW11079422HA M1176021-069587 SEW11079423HA M1176021-069587 SEW11079424HA M1176021-068615 SEW11079425HA M1176021-077172 SEW11079426HA M1176021-083051 SEW11079427HA M1176021-066211 SEW11079428HA M1176021-071488 SEW11079429HA M1176021-066211 SEW11079430HA M1176021-069586 SEW11079431HA M1176021-052037 SEW11079433HA M1176021-071108 SEW11079436HA M1176021-077172 SEW11079441HA M1176021-077172 SEW11079450HA M1176021-071250 SEW11079451HA M1176021-069587 SEW11079453HA M1176021-071488 SEW11079456HA M1176021-071488 SEW11079458HA M1176021-066211 SEW11079459HA M1176021-071488 SEW11079462HA M1176021-066211 SEW11079463HA M1176021-077172 SEW11079464HA M1176021-071488 SEW11079465HA M1176021-077172 SEW11079466HA M1176021-077172 SEW11079467HA M1176021-066795 SEW11079468HA M1176021-066795 SEW11079469HA M1176021-077172 SEW11079470HA M1176021-069587 SEW11079471HA M1176021-069587 SEW11079472HA M1176021-066211 SEW11079473HA M1176021-069587 SEW11079474HA M1176021-069587 SEW11079475HA M1176021-066795 SEW11079476HA M1176021-066795 SEW11079477HA M1176021-069587 SEW11079478HA M1176021-069587 SEW11079479HA M1176021-077172 SEW11079481HA M1176021-068615 SEW11079484HA M1176021-069587 SEW11079486HA M1176021-066795 SEW11079487HA M1176021-069587 SEW11079488HA M1176021-066211 SEW11079489HA M1176021-071488 SEW11079490HA M1176021-069587 SEW11079491HA M1176021-066211 SEW11079493HA M1176021-077172 SEW11079495HA M1176021-071488 SEW11079496HA M1176021-077172 SEW11079501HA M1176021-066211 SEW11079504HA M1176021-061908 SEW11079505HA M1176021-073046 SEW11079507HA M1176021-077172 SEW11079509HA M1176021-077172 SEW11079510HA M1176021-052037 SEW11079511HA M1176021-077172 SEW11079512HA M1176021-077172 SEW11079513HA M1176021-052037 SEW11079515HA M1176021-069586 SEW11079519HA M1176021-066355 SEW11079521HA M1176021-073046 SEW11079524HA M1176021-073046 SEW11079526HA M1176021-073046 SEW11079528HA M1176021-052037 SEW11079529HA M1176021-052037 SEW11079532HA M1176021-066795 SEW11079533HA M1176021-077889 SEW11079534HA M1176021-077172 SEW11079535HA M1176021-071488 SEW11079536HA M1176021-066211 SEW11079537HA M1176021-066795 SEW11079538HA M1176021-066795 SEW11079540HA M1176021-066795 SEW11079541HA M1176021-073046 SEW11079545HA M1176021-066795 SEW11079546HA M1176021-066795 SEW11079547HA M1176021-071108 SEW11100001HA M1176021-078228 SEW11100003HA M1176021-077889 SEW11100004HA M1176021-052037 SEW11100008HA M1176021-077889 SEW11100009HA M1176021-078228 SEW11100010HA M1176021-062617 SEW11100011HA M1176021-078234 SEW11100012HA M1176021-052037 SEW11100013HA M1176021-052037 SEW11100014HA M1176021-077889 SEW11100015HA M1176021-077889 SEW11100016HA M1176021-077889 SEW11100017HA M1176021-052037 SEW11100021HA M1176021-065536 SEW11100022HA M1176021-065536 SEW11100023HA M1176021-078234 SEW11100024HA M1176021-073046 SEW11100025HA M1176021-078234 SEW11100026HA M1176021-065536 SEW11100027HA M1176021-065536 SEW11100028HA M1176021-065536 SEW11100029HA M1176021-078234 SEW11100030HA M1176021-077889 SEW11100032HA M1176021-077889 SEW11100033HA M1176021-065536 SEW11100034HA M1176021-065536 SEW11100035HA M1176021-077889 SEW11100036HA M1176021-065536 SEW11100037HA M1176021-077889 SEW11100039HA M1176021-065536 SEW11100040HA M1176021-077889 SEW11100041HA M1176021-077889 SEW11100043HA M1176021-077889 SEW11100044HA M1176021-065536 SEW11100045HA M1176021-065536 SEW11100046HA M1176021-077889 SEW11100047HA M1176021-077889 SEW11100048HA M1176021-077889 SEW11100049HA M1176021-052037 SEW11100050HA M1176021-077889 SEW11100051HA M1176021-077889 SEW11100058HA M1176021-073046 SEW11100067HA M1205643-077912 SEW11100068HA M1205643-077912 SEW11100069HA M1205643-077912 SEW11100070HA M1205643-077912 SEW11100071HA M1205643-077912 SEW11100072HA M1205643-077912 SEW11100084HA M1205643-077912 SEW11100087HA M1205643-077912 SEW11100088HA M1205643-077912 SEW11100094HA M1205643-077912 SEW11100096HA M1205643-077912 SEW11100099HA M1205643-088364 SEW11100101HA M1205643-088364 SEW11100103HA M1205643-078388 SEW11100105HA M1205643-078388 SEW11100106HA M1205643-077912 SEW11100107HA M1205643-077912 SEW11100108HA M1205643-077912 SEW11100109HA M1205643-077912 SEW11100110HA M1205643-078388 SEW11100131HA M1205643-078388 SEW11100132HA M1205643-078388 SEW11100133HA M1205643-078388 SEW11100135HA M1205643-093210 SEW11100136HA M1205643-077912 SEW11100137HA M1205643-078388 SEW11100138HA M1205643-077912 SEW11100141HA M1205643-082868 SEW11100155HA M1205643-077912 SEW11100157HA M1205643-078388 SEW11109957HA M1176021-071488 SEW11109958HA M1176021-066795 SEW11109959HA M1176021-066795 SEW11109960HA M1176021-066795 SEW11109961HA M1176021-066795 SEW11109962HA M1176021-073046 SEW11109963HA M1176021-066355 SEW11109964HA M1176021-071488 SEW11109965HA M1176021-066795 SEW11109966HA M1176021-066795 SEW11109968HA M1176021-073046 SEW11109969HA M1176021-071488 SEW11109970HA M1176021-066872 SEW11109971HA M1176021-071488 SEW11109972HA M1176021-071488 SEW11109974HA M1176021-078228 SEW11109975HA M1176021-066795 SEW11109977HA M1176021-077889 SEW11109978HA M1176021-077889 SEW11109979HA M1176021-062617 SEW11109980HA M1176021-052037 SEW11109982HA M1176021-071488 SEW11109983HA M1176021-071488 SEW11109985HA M1176021-077889 SEW11109987HA M1176021-065536 SEW11109988HA M1176021-078228 SEW11109989HA M1176021-052037 SEW11109990HA M1176021-065536 SEW11109991HA M1176021-066355 SEW11109992HA M1176021-052037 SEW11109993HA M1176021-062617 SEW11109996HA M1176021-052037 SEW11109998HA M1176021-062617 SEW11109999HA M1176021-065536 SEW11120439HA M1205643-078388 SEW11120440HA M1205643-077912 SEW11120443HA M1205643-078388 SEW11120454HA M1205643-083502 SEW11120464HA M1205643-078388 SEW11120465HA M1205643-078388 SEW11120467HA M1205643-078388 SEW11120468HA M1205643-071516 SEW11120470HA M1205643-093210 SEW11120471HA M1205643-084347 SEW11120474HA M1176021-166902 SEW11120475HA M1205643-083502 SEW11120478HA M1205643-084347 SEW11120479HA M1205643-084347 SEW11120481HA M1205643-083502 SEW11120484HA M1205643-084347 SEW11120485HA M1176021-086199 SEW11130590HA M1176021-075931 SEW11130591HA M1176021-075931 SEW11130592HA M1176021-075931 SEW11130593HA M1176021-075931 SEW11130594HA M1176021-075931 SEW11130598HA M1176021-075931 SEW11130600HA M1176021-075931 SEW11130602HA M1176021-086199 SEW11130613HA M1205643-084347 SEW11130615HA M1205643-088364 SEW11130617HA M1205643-088364 SEW11130619HA M1205643-084347 SEW11130625HA M1205643-083502 SEW11130630HA M1205643-083502 SEW11130632HA M1205643-078388 SEW11130633HA M1205643-089146 SEW11130634HA M1205643-089146 SEW11130637HA M1205643-089146 SEW11130638HA M1205643-078388 SEW11130639HA M1205643-088364 SEW11130640HA M1205643-089146 SEW11130641HA M1205643-089146 SEW11130647HA M1205643-088364 SEW11130652HA M1205643-078388 SEW11130655HA M1205643-078388 SEW11130665HA M1205643-088364 SEW11130675HA M1176021-167442 SEW11130676HA M1176021-060804 SEW11140791HA M1205643-083502 SEW11140792HA M1205643-088364 SEW11140834HA M1205643-082868 SEW11140837HA M1205643-071516 SEW11140840HA M1205643-089146 SEW11140841HA M1205643-088364 SEW11140843HA M1205643-084347 SEW11140852HA M1205643-088364 SEW11140853HA M1205643-083502 SEW11140858HA M1205643-088364 SEW11140859HA M1205643-093210 SEW11140860HA M1176021-060804 SEW11140861HA M1176021-088607 SEW11140862HA M1205643-083502 SEW11140864HA M1205643-083502 SEW11140870HA M1205643-082868 SEW11140873HA M1205643-078388 SEW11140877HA M1205643-082868 SEW11140882HA M1205643-088364 SEW11141008HA M1176021-096424 SEW11141009HA M1205643-088364 SEW11141014HA M1205643-088364 SEW11141056HA M1176021-077889 SEW11141057HA M1176021-052037 SEW11141065HA M1176021-078228 SEW11141070HA M1176021-075931 SEW11141071HA M1176021-075339 SEW11141072HA M1176021-075339 SEW11141073HA M1176021-075931 SEW11141074HA M1176021-075931 SEW11141077HA M1176021-074510 SEW11141078HA M1176021-075931 SEW11141079HA M1176021-074510 SEW11141080HA M1176021-074510 SEW11141081HA M1176021-075931 SEW11141086HA M1176021-077106 SEW11151188HA M1176021-052037 SEW11151191HA M1176021-074849 SEW11151192HA M1176021-052037 SEW11151193HA M1176021-074849 SEW11151194HA M1176021-074849 SEW11151195HA M1176021-052037 SEW11151196HA M1176021-075931 SEW11151197HA M1176021-074849 SEW11151198HA M1176021-074849 SEW11151199HA M1176021-074849 SEW11151200HA M1176021-075931 SEW11151202HA M1176021-075931 SEW11151203HA M1176021-075931 SEW11151204HA M1176021-074849 SEW11151205HA M1176021-075931 SEW11151207HA M1176021-075931 SEW11151208HA M1176021-075931 SEW11151209HA M1176021-074849 SEW11151210HA M1176021-074510 SEW11151211HA M1176021-075931 SEW11151212HA M1176021-086199 SEW11151213HA M1176021-075931 SEW11151214HA M1176021-075931 SEW11151215HA M1176021-075931 SEW11151216HA M1176021-075931 SEW11151217HA M1176021-075339 SEW11151219HA M1176021-074510 SEW11151231HA M1176021-078234 SEW11151233HA M1176021-074510 SEW11151236HA M1176021-078234 SEW11151237HA M1176021-075931 SEW11151239HA M1176021-078234 SEW11151255HA M1176021-074510 SEW11151257HA M1176021-075931 SEW11151263HA M1176021-064120 SEW11151266HA M1176021-062617 SEW11151269HA M1176021-076491 SEW11151274HA M1176021-074849 SEW11151284HA M1176021-074849 SEW11151285HA M1176021-075931 SEW11151286HA M1176021-094311 SEW11171442HA M1176021-080617 SEW11171454HA M1176021-064120 SEW11171455HA M1176021-075931 SEW11171456HA M1176021-075931 SEW11171457HA M1176021-064120 SEW11171462HA M1176021-066211 SEW11171464HA M1176021-066355 SEW11171472HA M1176021-052037 SEW11171478HA M1176021-077889 SEW11171480HA M1176021-094311 SEW11171486HA M1176021-078228 SEW11171499HA M1176021-062617 SEW11171503HA M1176021-062617 SEW11171507HA M1176021-062617 SEW11171511HA M1176021-052037 SEW11171525HA M1176021-052037 SEW11171526HA M1176021-074849 SEW11171527HA M1176021-052037 SEW11171530HA M1176021-080698 SEW11171531HA M1176021-079879 SEW11171532HA M1176021-052037 SEW11171533HA M1176021-052037 SEW11171534HA M1176021-062617 SEW11171539HA M1176021-062617 SEW11181752HA M1176021-080617 SEW11181753HA M1176021-062617 SEW11181758HA M1176021 SEW11181770HA M1176021-062617 SEW11181773HA M1176021-052037 SEW11181774HA M1176021-052037 SEW11181775HA M1176021-052037 SEW11181776HA M1176021-080617 SEW11181778HA M1176021-074849 SEW11181779HA M1176021 SEW11181781HA M1176021-052037 SEW11181782HA M1176021-052037 SEW11181785HA M1176021-080617 SEW11181787HA M1176021-079879 SEW11181788HA M1176021-066355 SEW11181790HA M1176021-080617 SEW11181791HA M1176021-064120 SEW11181792HA M1176021-066355 SEW11181794HA M1176021-066355 SEW11181797HA M1176021-077889 SEW11181800HA M1176021-066355 SEW11181813HA M1176021-080698 SEW11181823HA M1176021-062617 SEW11181828HA M1176021-062617 SEW11181834HA M1176021-082294 SEW11181837HA M1176021-082294 SEW11181838HA M1176021-082294 SEW11181839HA M1176021-082294 SEW11181842HA M1176021-082294 SEW11181848HA M1176021-079879 SEW11181852HA M1176021-082294 SEW11181854HA M1176021-065536 SEW11181856HA M1176021-083065 SEW11181857HA M1176021-079879 SEW11181858HA M1176021-083051 SEW11181859HA M1176021-083051 SEW11181862HA M1176021-083051 SEW11181863HA M1176021-083051 SEW11181866HA M1176021-071250 SEW11181867HA M1176021-071250 SEW11181869HA M1176021-082293 SEW11181871HA M1176021-071250 SEW11181873HA M1176021-065536 SEW11181875HA M1176021-083065 SEW11181876HA M1176021-071250 SEW11181882HA M1176021-080617 SEW11181886HA M1176021-080698 SEW11181892HA M1176021-079879 SEW11181894HA M1176021-082293 SEW11181895HA M1176021-080617 SEW11181896HA M1176021-082294 SEW11181897HA M1176021-082294 SEW11181898HA M1176021-082294 SEW11181899HA M1176021-082294 SEW11181900HA M1176021-066355 SEW11181904HA M1176021-077889 SEW11181905HA M1176021-066355 SEW11181906HA M1176021-077889 SEW11181908HA M1176021-052037 SEW11181909HA M1176021-086199 SEW11181910HA M1176021-071250 SEW11181911HA M1176021-071250 SEW11181912HA M1176021-071250 SEW11181913HA M1176021-083051 SEW11181914HA M1176021-066355 SEW11181915HA M1176021-071250 SEW11181916HA M1176021-083051 SEW11181917HA M1176021-071250 SEW11181919HA M1176021-052037 SEW11181920HA M1176021-079879 SEW11181921HA M1176021-083051 SEW11181922HA M1176021-083051 SEW11181923HA M1176021-079879 SEW11181925HA M1176021-052037 SEW11181926HA M1176021-083065 SEW11181927HA M1176021-083065 SEW11181928HA M1176021-083065 SEW11181930HA M1176021-071250 SEW11181932HA M1176021-085341 SEW11181936HA M1176021-052037 SEW11181941HA M1176021-079879 SEW11181942HA M1176021-052037 SEW11181943HA M1176021-052037 SEW11181947HA M1176021-052037 SEW11181949HA M1176021-052037 SEW11202202HA M1176021-052037 SEW11202203HA M1176021-079879 SEW11202204HA M1176021-052037 SEW11202220HA M1176021-079668 SEW11202222HA M1205643-093693 SEW11202223HA M1205643-088364 SEW11202228HA M1205643-093693 SEW11202230HA M1205643-093693 SEW11202232HA M1205643-093693 SEW11202258HA M1205643-088364 SEW11202260HA M1205643-083502 SEW11202263HA M1205643-082868 SEW11202264HA M1205643-088364 SEW11202266HA M1205643-088364 SEW11202277HA M1205643-089146 SEW11202283HA M1176021-079879 SEW11202286HA M1176021-052037 SEW11202287HA M1176021-062617 SEW11202288HA M1176021-066355 SEW11202290HA M1176021-052037 SEW11202291HA M1176021-052037 SEW11202294HA M1176021-052037 SEW11202296HA M1176021-052037 SEW11202298HA M1176021-052037 SEW11202299HA M1176021-052037 SEW11202301HA M1176021-066211 SEW11202304HA M1176021-052037 SEW11202306HA M1176021-066355 SEW11202307HA M1176021-052037 SEW11202309HA M1176021-077889 SEW11202310HA M1176021-062617 SEW11202313HA M1176021-079049 SEW11202317HA M1176021-062617 SEW11202319HA M1176021-052037 SEW11202320HA M1176021-052037 SEW11202321HA M1176021-052037 SEW11202322HA M1176021-077889 SEW11202323HA M1176021-062617 SEW11202325HA M1176021-052037 SEW11202328HA M1176021-052037 SEW11202329HA M1176021-052037 SEW11202331HA M1176021-052037 SEW11202332HA M1176021-052037 SEW11202333HA M1176021-052037 SEW11202334HA M1176021-052037 SEW11202335HA M1176021-052037 SEW11202336HA M1176021-066355 SEW11202337HA M1176021-052037 SEW11202338HA M1176021-052037 SEW11202340HA M1176021-052037 SEW11202341HA M1176021-052037 SEW11202343HA M1176021-052037 SEW11202346HA M1176021-052037 SEW11202347HA M1176021-052037 SEW11202348HA M1176021-052037 SEW11202349HA M1176021-052037 SEW11202350HA M1176021-052037 SEW11202351HA M1176021-052037 SEW11202352HA M1176021-062617 SEW11202353HA M1176021-062617 SEW11202356HA M1176021-052037 SEW11202357HA M1176021-052037 SEW11202358HA M1176021-052037 SEW11202359HA M1176021-052037 SEW11202360HA M1176021-052037 SEW11202361HA M1176021-052037 SEW11202362HA M1176021-052037 SEW11202363HA M1176021-052037 SEW11202364HA M1176021-052037 SEW11202365HA M1176021-052037 SEW11202366HA M1176021-052037 SEW11202368HA M1176021-052037 SEW11202369HA M1176021-052037 SEW11202370HA M1176021-052037 SEW11202371HA M1176021-066355 SEW11202372HA M1176021-052037 SEW11202378HA M1176021-080698 SEW11202379HA M1176021-080698 SEW11202380HA M1176021-052037 SEW11202381HA M1176021-062617 SEW11202383HA M1176021-079879 SEW11202384HA M1176021-079879 SEW11202385HA M1176021-079879 SEW11202390HA M1176021-079668 SEW11202391HA M1176021-052037 SEW11202394HA M1176021-080617 SEW11202395HA M1176021-080617 SEW11202397HA M1176021-079879 SEW11202398HA M1176021-080617 SEW11202399HA M1176021-079879 SEW11202400HA M1176021-079879 SEW11202401HA M1176021-079879 SEW11202682HA M1176021-079879 SEW11202687HA M1176021-079879 SEW11202690HA M1176021-079879 SEW11202693HA M1176021-052037 SEW11202696HA M1176021-052037 SEW11202697HA M1176021-079668 SEW11202700HA M1176021-052037 SEW11202702HA M1176021-052037 SEW11202703HA M1176021-052037 SEW11202704HA M1176021-052037 SEW11202705HA M1176021-052037 SEW11202706HA M1176021-052037 SEW11202707HA M1176021-052037 SEW11202708HA M1176021-052037 SEW11202709HA M1176021-080698 SEW11202711HA M1176021-052037 SEW11202712HA M1176021-052037 SEW11202713HA M1176021-080698 SEW11202715HA M1176021-080698 SEW11202716HA M1176021-062617 SEW11202717HA M1176021-080698 SEW11202719HA M1176021-080698 SEW11202728HA M1176021-066355 SEW11202731HA M1176021-082199 SEW11202736HA M1176021-080698 SEW11202737HA M1176021-079879 SEW11202739HA M1176021-079879 SEW11202740HA M1176021-080617 SEW11202741HA M1176021-079879 SEW11202742HA M1176021-080617 SEW11202744HA M1176021-079879 SEW11202745HA M1176021-079879 SEW11202746HA M1176021-079879 SEW11202747HA M1176021-066355 SEW11202749HA M1176021-079879 SEW11202750HA M1176021-080617 SEW11202753HA M1176021-080617 SEW11202769HA M1176021-085262 SEW11202775HA M1176021-066355 SEW11202778HA M1176021-066355 SEW11202780HA M1176021-080260 SEW11222997HA M1176021-080260 SEW11222999HA M1176021-080260 SEW11223011HA M1176021-066355 SEW11223019HA M1176021-080260 SEW11223020HA M1176021-066355 SEW11223022HA M1176021-066355 SEW11223070HA M1176021-079879 SEW11223081HA M1176021-082199 SEW11223082HA M1176021-079879 SEW11223085HA M1176021-080617 SEW11223086HA M1176021-079879 SEW11223092HA M1176021-079879 SEW11223103HA M1176021-083500 SEW11223106HA M1176021-066355 SEW11223107HA M1176021-079879 SEW11223108HA M1176021-079879 SEW11223121HA M1176021-080617 SEW11223122HA M1176021-080617 SEW11223123HA M1176021-066355 SEW11223128HA M1205643-083502 SEW11223129HA M1205643-157761 SEW11223130HA M1205643-083502 SEW11223132HA M1205643-088364 SEW11223134HA M1205643-088364 SEW11223136HA M1176021-096424 SEW11223140HA M1176021-096424 SEW11243338HA M1205643-089145 SEW11243339HA M1176021-096424 SEW11243341HA M1176021-093063 SEW11243343HA M1176021-093063 SEW11243344HA M1176021-093063 SEW11243345HA M1176021-093063 SEW11243348HA M1205643-088364 SEW11243349HA M1205643-088364 SEW11243350HA M1176021-093063 SEW11243353HA M1176021-096424 SEW11243354HA M1176021-096424 SEW11243357HA M1205643-157761 SEW11243358HA M1205643-088364 SEW11243359HA M1205643-088364 SEW11243360HA M1205643-089146 SEW11243361HA M1176021-096424 SEW11243362HA M1176021-096424 SEW11243364HA M1205643-078388 SEW11243365HA M1176021-096424 SEW11243366HA M1176021-096424 SEW11243368HA M1205643-157761 SEW11243369HA M1176021-096424 SEW11243370HA M1176021-096424 SEW11243371HA M1176021-096424 SEW11243372HA M1176021-096424 SEW11243373HA M1176021-096424 SEW11243374HA M1205643-157761 SEW11243375HA M1176021-096424 SEW11243376HA M1176021-096424 SEW11243377HA M1176021-096424 SEW11243378HA M1176021-096424 SEW11243379HA M1176021-096424 SEW11243380HA M1176021-096424 SEW11243381HA M1176021-096424 SEW11243382HA M1176021-096424 SEW11243389HA M1205643-088364 SEW11243408HA M1176021-066355 SEW11243416HA M1176021-066355 SEW11243419HA M1176021-066355 SEW11243420HA M1176021-066355 SEW11243421HA M1176021-066355 SEW11243422HA M1176021-066355 SEW11243423HA M1176021-066355 SEW11243427HA M1176021-083051 SEW11243428HA M1176021-066355 SEW11243432HA M1176021-083065 SEW11243437HA M1176021-062617 SEW11243438HA M1176021-062617 SEW11243441HA M1176021-083065 SEW11243442HA M1176021-083065 SEW11243443HA M1176021-066355 SEW11243447HA M1176021-064120 SEW11243450HA M1176021-066355 SEW11243451HA M1176021-066355 SEW11243452HA M1176021-066355 SEW11243453HA M1176021-064120 SEW11243454HA M1176021-062617 SEW11243456HA M1176021-066355 SEW11243457HA M1176021-066355 SEW11243458HA M1176021-083065 SEW11243459HA M1176021-066355 SEW11243461HA M1176021-082199 SEW11243462HA M1176021-082199 SEW11243463HA M1176021-082199 SEW11243464HA M1176021-084804 SEW11243465HA M1176021-082199 SEW11243466HA M1176021-082199 SEW11243467HA M1176021-082199 SEW11243468HA M1176021-082199 SEW11243469HA M1176021-082199 SEW11243470HA M1176021-082199 SEW11243471HA M1176021-082199 SEW11243473HA M1176021-082199 SEW11243475HA M1176021-082199 SEW11243477HA M1176021-082199 SEW11243478HA M1176021-066355 SEW11243479HA M1176021-082199 SEW11243480HA M1176021-082199 SEW11243484HA M1176021-082199 SEW11243485HA M1176021-082199 SEW11243488HA M1176021-144352 SEW11243490HA M1176021-077889 SEW11243499HA M1176021-062617 SEW11243502HA M1176021-066355 SEW11243504HA M1176021-077889 SEW11243505HA M1176021-074510 SEW11243506HA M1176021-077889 SEW11243507HA M1176021-082199 SEW11243508HA M1176021-082199 SEW11243512HA M1176021-082199 SEW11243514HA M1176021-077889 SEW11243524HA M1176021-080057 SEW11263781HA M1176021-082474 SEW11263782HA M1176021-082474 SEW11263783HA M1176021-083862 SEW11263795HA M1176021-083051 SEW11263796HA M1176021-083051 SEW11263797HA M1176021-083051 SEW11263885HA M1176021-083051 SEW11263886HA M1176021-071250 SEW11263887HA M1176021-071250 SEW11263888HA M1176021-066355 SEW11263889HA M1176021-066211 SEW11263890HA M1176021-066211 SEW11263891HA M1176021-066211 SEW11263892HA M1176021-083051 SEW11263893HA M1176021-066211 SEW11263895HA M1176021-077889 SEW11263898HA M1176021-077889 SEW11263900HA M1176021-077889 SEW11263903HA M1176021-077889 SEW11263943HA M1176021-082474 SEW11263959HA M1176021-082474 SEW11263960HA M1176021-082474 SEW11263961HA M1176021-082474 SEW11263962HA M1176021-082474 SEW11263965HA M1176021-119629 SEW11263966HA M1176021-082474 SEW11263967HA M1176021-082474 SEW11263969HA M1176021-066355 SEW11263970HA M1176021-082474 SEW11263973HA M1176021-115826 SEW11263974HA M1176021-077889 SEW11314009HA M1176021-071250 SEW11314011HA M1176021-084419 SEW11314015HA M1176021-084419 SEW11314016HA M1176021-115093 SEW11314018HA M1176021-107004 SEW11314019HA M1176021-077889 SEW11314020HA M1176021-077889 SEW11314022HA M1176021-084346 SEW11314024HA M1176021-115093 SEW11314025HA M1176021-115826 SEW11314026HA M1176021-084419 SEW11314027HA M1176021-084419 SEW11314041HA M1176021-077889 SEW11314058HA M1176021-084759 SEW11314060HA M1176021-077889 SEW11314061HA M1176021-077889 SEW11314064HA M1176021-077889 SEW11314075HA M1176021-077889 SEW11314080HA M1176021-077889 SEW11314082HA M1176021-077889 SEW11314083HA M1176021-077889 SEW11314084HA M1176021-077889 SEW11314085HA M1176021-077889 SEW11314086HA M1176021-077889 SEW11314087HA M1176021-077889 SEW11314088HA M1176021-168003 SEW11314089HA M1176021-077889 SEW11314090HA M1176021-077889 SEW11314091HA M1176021-077889 SEW11314092HA M1176021-077889 SEW11314093HA M1176021-077889 SEW11314094HA M1176021-077889 SEW11314099HA M1176021-077889 SEW11314100HA M1176021-077889 SEW11314101HA M1176021-077889 SEW11314102HA M1176021-082199 SEW11314103HA M1176021-082199 SEW11314104HA M1176021-077889 SEW11314105HA M1176021-077889 SEW11314106HA M1176021-065536 SEW11324217HA M1176021-089787 SEW11324221HA M1176021-077889 SEW11324223HA M1176021-065536 SEW11324224HA M1176021-077889 SEW11324225HA M1176021-077889 SEW11324226HA M1176021-065536 SEW11324227HA M1176021-065536 SEW11324228HA M1176021-077889 SEW11324229HA M1176021-065536 SEW11324230HA M1176021-086199 SEW11324231HA M1176021-077889 SEW11324232HA M1176021-077889 SEW11324234HA M1176021-065536 SEW11324237HA M1176021-077889 SEW11324241HA M1176021-085341 SEW11324243HA M1176021-084419 SEW11324247HA M1176021-084419 SEW11324250HA M1176021-065536 SEW11324251HA M1176021-065536 SEW11324254HA M1176021-065536 SEW11324255HA M1176021-065536 SEW11324256HA M1176021-065536 SEW11324258HA M1176021-065536 SEW11324259HA M1176021-065536 SEW11324261HA M1176021-084804 SEW11324262HA M1176021-084804 SEW11324263HA M1176021-084804 SEW11324264HA M1176021-084804 SEW11324265HA M1176021-084804 SEW11324266HA M1176021-084804 SEW11324268HA M1176021-084804 SEW11324275HA M1176021-077889 SEW11324277HA M1176021-077889 SEW11324278HA M1176021-077889 SEW11324279HA M1176021-077889 SEW11324280HA M1176021-077889 SEW11324281HA M1176021-077889 SEW11324282HA M1176021-077889 SEW11324295HA M1176021-077889 SEW11324296HA M1176021-077889 SEW11324297HA M1176021-077889 SEW11324298HA M1176021-062617 SEW11324299HA M1176021-084804 SEW11324300HA M1176021-084804 SEW11324301HA M1176021-084804 SEW11324302HA M1176021-084804 SEW11324303HA M1176021-084804 SEW11324304HA M1176021-084804 SEW11324305HA M1176021-085779 SEW11324306HA M1176021-085779 SEW11324309HA M1176021-062617 SEW11324310HA M1176021-085341 SEW11324311HA M1176021-077889 SEW11324312HA M1176021-084404 SEW11324313HA M1176021-084404 SEW11324314HA M1176021-084404 SEW11324316HA M1176021-084404 SEW11324317HA M1176021-084404 SEW11324318HA M1176021-084404 SEW11324320HA M1176021-084404 SEW11324322HA M1176021-0
Other Recalls from GE Healthcare, LLC
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1566-2022 | Class II | (1) GE Centricity Universal Viewer 6.0, Model 2... | Jul 15, 2022 |
| Z-1430-2022 | Class II | SIGNA Premier magnetic resonance scanner, model... | Jun 24, 2022 |
| Z-1466-2022 | Class II | Centricity PACS Software Version 7.0 SP0.0.4.7 | Jun 14, 2022 |
| Z-1333-2022 | Class II | GE Centricity Universal Viewer Zero Footprint. ... | Jun 8, 2022 |
| Z-1511-2022 | Class II | Service manuals for the CT, PET, or NM table as... | Jun 2, 2022 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.