Carestation 620 A1, Carestation 650 A1, and Carestation 650c A1
FDA Device Recall #Z-2703-2017 — Class II — May 2, 2017
Recall Summary
| Recall Number | Z-2703-2017 |
| Classification | Class II — Moderate risk |
| Date Initiated | May 2, 2017 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | GE Healthcare, LLC |
| Location | Waukesha, WI |
| Product Type | Devices |
| Quantity | 3,448 (334 US; 3,114 OUS) |
Product Description
Carestation 620 A1, Carestation 650 A1, and Carestation 650c A1
Reason for Recall
Carestation 620, 650 and 650c has Potential for Elevated FiCO2 and Unexpected System Malfunction
Distribution Pattern
US Distribution including PR and to the states of : AL, AR, AZ, CA, CO, CT, FL GA, ID,IL, IN, KY, LA, , MA, MD, MI, MO, MS, MT, MN, NC, NH, NJ, NV, NY, OH, OK, PA, TN, TX, VA, WA, WI, and UT. OUS: Algeria Argentina Australia Austria Belgium Bolivia Bosnia and Herzegovina Brazil Bulgaria Cambodia Canada Chile Colombia Costa Rica Cote d'Ivoire Croatia Czech Republic Ecuador Egypt El Salvador Estonia Finland France Germany Greece Honduras Hong Kong Hungary India Indonesia Iraq Ireland Israel Italy Japan Jordan Kenya Korea (Republic Of) Kuwait Latvia Lebanon Lithuania Malaysia Maldives Malta Mauritius Mexico Moldova Morocco Myanmar Netherlands New Zealand Nigeria Norway Oman Pakistan Paraguay Peru Philippines Poland Portugal Romania Russia Saudi Arabia Senegal Serbia Singapore Slovakia Slovenia South Africa Spain Sweden Switzerland Taiwan Tanzania Thailand Turkey United Arab Emirates United Kingdom Uruguay Vietnam Zimbabwe
Lot / Code Information
Carestation 620 A1: SM616460036MA SM616460037MA SM616400001MA SM616250007MA SM616340023MA SM616460048MA SM616460049MA SM616460022MA SM616250005MA SM616400004MA SM616400005MA SM617110011MA SM617110012MA SM617110013MA SM617110014MA SM616430024MA SM616200020MA SM616200019MA SM616200021MA SM616200022MA SM616200023MA SM616200024MA SM617010108MA SM616270021MA SM616270022MA SM617020019MA SM617020020MA SM617020021MA SM616460047MA SM616340001MA SM616340002MA SM616340039MA SM616340025MA SM616460052MA SM616460053MA SM616460054MA SM616460055MA SM616460056MA SM616460057MA SM616250006MA SM616460035MA SM617010114MA SM617010115MA SM617010116MA SM617010117MA SM617010118MA SM616340027MA SM616410061MA SM616340018MA SM616340019MA SM616340020MA SM616460030MA SM616460028MA SM616460029MA SM616410043MA SM617020010MA SM617020011MA SM617020012MA SM617020013MA SM617020014MA SM617020015MA SM617020016MA SM617020017MA SM617020018MA SM617060084MA SM617100056MA SM617100057MA SM616400016MA SM616400017MA SM616170021MA SM616170022MA SM616200012MA SM616340028MA SM616340029MA SM616340030MA SM617100058MA SM616340021MA SM616430034MA SM616430035MA SM617100157MA SM616250001MA SM616250002MA SM616250003MA SM616250004MA SM617100019MA SM617100020MA SM617100021MA SM617100022MA SM617100023MA SM617100024MA SM617100025MA SM617020026MA SM616100020MA SM616100021MA SM616100022MA SM616100023MA SM616100024MA SM616200013MA SM616200016MA SM616200014MA SM616200015MA SM617020007MA SM617020008MA SM617020009MA SM615500007WA SM616150007WA SM616220004WA SM616220005WA SM616220006WA SM616370002WA SM616370003WA SM616370005WA SM616370006WA SM616450003WA SM617030015WA SM617030016WA SM617030017WA SM617040018WA SM617040019WA SM617040020WA SM617040021WA SM617040022WA SM617040023WA SM617060001WA SM617060002WA SM617060003WA SM617060004WA SM617120006WA SM617120007WA SM617080015WA SM617080016WA SM617080017WA SM617080018WA SM617080019WA SM617080020WA SM617080021WA SM617080022WA SM616400019MA SM616400020MA SM616460023MA SM616460024MA SM616460025MA SM616460026MA SM616460027MA SM617050039MA SM616330011WA SM616330012WA SM617040001WA SM615520001WA SM615520002WA SM615520003WA SM616240002WA SM616340049WA SM616340050WA SM616240001WA SM615390002WA SM615390003WA SM615390004WA SM616430045WA SM616430046WA SM616270025WA SM616270026WA SM616220009WA SM616220010WA SM616220011WA SM616340043WA SM615430004WA SM616140005WA SM616140006WA SM616280020WA SM616280021WA SM615390001WA SM616330002WA SM616330003WA SM616330004WA SM616280005WA SM616280006WA SM616280007WA SM616280008WA SM616280009WA SM616280010WA SM616280011WA SM616280012WA SM616280013WA SM616280014WA SM616280015WA SM616280016WA SM616280017WA SM616280018WA SM616280019WA SM616400021WA SM616400022WA SM616400023WA SM616190005WA SM615500005WA SM616210004WA SM616460005WA SM616460006WA SM616460007WA SM616460008WA SM616460009WA SM616320002MA SM616320003MA SM616410012MA SM616410013MA SM616410014MA SM616440003WA SM616500002WA SM616500003WA SM616500004WA SM616510001WA SM616510002WA SM616510003WA SM616510004WA SM616170018WA SM616290001WA SM616030001WA SM616030002WA SM616030003WA SM616030004WA SM616030005WA SM616170007WA SM616440006WA SM616170008WA SM616150014WA SM616350001WA SM616350003WA SM616410025WA SM616410026WA SM617030018WA SM617030019WA SM617030020WA SM617030021WA SM617030022WA SM617030023WA SM617030024WA SM616150013WA SM616290002WA SM616290003WA SM616290004WA SM616290005WA SM616290006WA SM616150010WA SM616170010WA SM616170011WA SM616170012WA SM616170013WA SM616410031WA SM616410039WA SM616410040WA SM616150011WA SM616150012WA SM617040011WA SM617040013WA SM616290007WA SM616350004WA SM616410002WA SM616410023WA SM616410027WA SM616410028WA SM616410029WA SM616410036WA SM616420001WA SM616430041WA SM616430060WA SM616500001WA SM616510005WA SM616510006WA SM616510007WA SM616510008WA SM616510009WA SM616510010WA SM617010120WA SM617010121WA SM617010122WA SM617010123WA SM617030038WA SM617030039WA SM617080001WA SM617080002WA SM617080003WA SM616160007WA SM616160008WA SM617030033WA SM617030034WA SM616290008WA SM616410037WA SM616420002WA SM616150015WA SM616160005WA SM616160006WA SM616020006WA SM616020007WA SM616020008WA SM616410030WA SM616410035WA SM616290015WA SM616290016WA SM616290017WA SM616290019WA SM616290020WA SM616330015WA SM616330016WA SM615490002WA SM615490003WA SM615490007WA SM615490008WA SM615490009WA SM615490011WA SM616020009WA SM616020010WA SM616020012WA SM616170006WA SM616170016WA SM616430052WA SM616430053WA SM616430054WA SM616430055WA SM616430056WA SM616430057WA SM616430058WA SM616430059WA SM616430062WA SM615500002WA SM616050005WA SM616170019WA SM616170020WA SM616430061WA SM616350002WA SM616410024WA SM616300005WA SM616300006WA SM616330005WA SM616430063WA SM616430064WA SM617060140WA SM616440001WA SM616440002WA SM616020011WA SM616170014WA SM617040008WA SM616410038WA SM616020003WA SM616410033WA SM616410034WA SM617040014WA SM617040016WA SM617040017WA SM616430051WA SM616510011WA SM617020028WA SM617020029WA SM617020030WA SM617020031WA SM617020032WA SM617020033WA SM617020034WA SM617030025WA SM617030026WA SM617030027WA SM617030028WA SM617030029WA SM617030030WA SM617030031WA SM617030032WA SM617030037WA SM617030040WA SM617040009WA SM617040010WA SM617040012WA SM617040015WA SM617060128WA SM617060129WA SM617060130WA SM617060131WA SM617060132WA SM617060133WA SM617060134WA SM617060135WA SM617060136WA SM617060137WA SM617060138WA SM617060139WA SM617070010WA SM617070011WA SM617070012WA SM617070013WA SM617070014WA SM617070015WA SM617070016WA SM617070017WA SM617070018WA SM617070019WA SM617070020WA SM617070021WA SM617070023WA SM617070024WA SM617070025WA SM617070026WA SM617070027WA SM617070028WA SM617070029WA SM617070030WA SM617070031WA SM617070032WA SM617070033WA SM617070034WA SM617070035WA SM617070036WA SM617070037WA SM617070038WA SM617070039WA SM617070040WA SM617070041WA SM617070042WA SM617070043WA SM617070044WA SM617070045WA SM617070046WA SM617070047WA SM617070048WA SM617070049WA SM617080004WA SM617080005WA SM617080006WA SM617080007WA SM617080008WA SM617080009WA SM617080010WA SM617080011WA SM617080012WA SM617080013WA SM617080014WA SM617080023WA SM617080024WA SM617080025WA SM617080026WA SM617080027WA SM617080028WA SM617080029WA SM617080030WA SM617080031WA SM617090020WA SM617090021WA SM617090022WA SM617090023WA SM617090024WA SM617090025WA SM617090026WA SM617090027WA SM617090028WA SM617090029WA SM617090030WA SM617090031WA SM616170009WA SM616290018WA SM615500003WA SM616440005WA SM617030035WA SM617030036WA SM616020004WA SM616440004WA SM617020001WA SM617020002WA SM617020003WA SM617020004WA SM617020005WA SM616160003WA SM616160004WA SM616330013WA SM616330014WA SM617100026MA SM617100027MA SM616430026MA SM616200018MA SM616430025MA SM617100155MA SM617100018MA SM616310012MA SM616310029MA SM616140003WA SM616140004WA SM616280022MA SM616280023MA SM616280024MA SM616280025MA SM616400007MA SM616400008MA SM616400009MA SM616400010MA SM616400011MA SM617010109MA SM617010110MA SM617010111MA SM617010112MA SM617010113MA SM617100158MA SM617100159MA SM617100160MA SM616050004WA SM616070003WA SM616170001WA SM616170003WA SM616170005WA SM617010124WA SM617010125WA SM617010126WA SM617010127WA SM617010128WA SM617010132WA SM617010133WA SM617010134WA SM617010135WA SM617060126WA SM617060127WA SM616340014MA SM616340015MA SM616340016MA SM616400018MA SM616410044MA SM616410045MA SM616410046MA SM616410047MA SM617010106MA SM617010107MA SM617010119MA SM617100151MA SM617100152MA SM616150001WA SM616410032WA SM616270002WA SM617040004WA SM617020022MA SM617020023MA SM616100005MA SM616100006MA SM617060098MA SM617060099MA SM617060100MA SM616280028MA SM616280029MA SM616280030MA SM616280031MA SM616300009MA SM616300010MA SM616300011MA SM616300012MA SM616300014MA SM616300015MA SM616300016MA SM616300017MA SM616300018MA SM616310001MA SM616310002MA SM616310003MA SM616310004MA SM616310005MA SM616310006MA SM616310007MA SM616310008MA SM616310009MA SM616310010MA SM616310011MA SM617050009MA SM617050010MA SM617050011MA SM617050012MA SM617050013MA SM617050014MA SM617050015MA SM617050016MA SM617050017MA SM617050018MA SM617050019MA SM617050020MA SM617050021MA SM617050022MA SM617050023MA SM617050024MA SM617050025MA SM617050026MA SM617050027MA SM617050028MA SM617050029MA SM617050030MA SM617050031MA SM617050032MA SM617050033MA SM617050034MA SM617050035MA SM617050036MA SM617050037MA SM617050038MA SM617060006MA SM617060007MA SM617060008MA SM617060009MA SM617060010MA SM617060011MA SM617060012MA SM617060013MA SM617060014MA SM617060015MA SM617060016MA SM617060017MA SM617060018MA SM617060019MA SM617060020MA SM617060021MA SM617060022MA SM617060023MA SM617060024MA SM617060025MA SM617060026MA SM617060027MA SM617060028MA SM617060029MA SM617060030MA SM617060031MA SM617060032MA SM617060033MA SM617060034MA SM617060035MA SM617060039MA SM617060040MA SM617060041MA SM617060042MA SM617060043MA SM617060044MA SM617060045MA SM617060046MA SM617060047MA SM617060048MA SM617060049MA SM617060050MA SM617060051MA SM617060052MA SM617060053MA SM617060054MA SM617060055MA SM617060056MA SM617060057MA SM617060058MA SM617060059MA SM617060060MA SM617060061MA SM617060062MA SM617060063MA SM617060064MA SM617060065MA SM617060066MA SM617060067MA SM617060068MA SM617060069MA SM617060070MA SM617060071MA SM617060072MA SM617060073MA SM617060074MA SM617060075MA SM617060076MA SM617060077MA SM617060078MA SM617060079MA SM617060080MA SM617060081MA SM617060082MA SM617060083MA SM617100028MA SM617100029MA SM617100030MA SM617100031MA SM617100032MA SM617100033MA SM617100034MA SM617100035MA SM617100036MA SM617100037MA SM617100038MA SM617100039MA SM617100040MA SM617100041MA SM617100042MA SM617100043MA SM617100044MA SM617100045MA SM617100046MA SM617100047MA SM617100048MA SM617100049MA SM617100050MA SM617100051MA SM617100052MA SM617100053MA SM617100054MA SM617100055MA SM617100071MA SM617100072MA SM617100073MA SM617100074MA SM617100075MA SM617100076MA SM617100077MA SM617100078MA SM617100079MA SM617100080MA SM617100081MA SM617100082MA SM617100083MA SM617100084MA SM617100085MA SM617100086MA SM617100087MA SM617100088MA SM617100089MA SM617100090MA SM617100091MA SM617100092MA SM617100093MA SM617100094MA SM617100095MA SM617100096MA SM617100097MA SM617100098MA SM617100099MA SM617100100MA SM617100101MA SM617100102MA SM617100103MA SM617100104MA SM617100105MA SM617100106MA SM617100107MA SM617100108MA SM617100109MA SM617100110MA SM617100111MA SM617100112MA SM617100113MA SM617100114MA SM617100115MA SM617100116MA SM617100117MA SM617100118MA SM617100119MA SM617100120MA SM617100121MA SM617100122MA SM617100123MA SM617100124MA SM617100125MA SM617100126MA SM617100127MA SM617100128MA SM617100131MA SM617100132MA SM616400012MA SM616400013MA SM615500008WA SM616480018WA SM616480019WA SM616450006WA SM616320024WA SM617020035WA SM617020036WA SM615030014WA SM616340022MA SM616410056MA SM616410057MA SM616460031MA SM616460032MA SM616460033MA SM616460034MA SM616400014MA SM616280032WA SM617110001WA SM617110002WA SM617110003WA SM615370001WA SM616440025WA SM616100033WA SM615350082WA SM615350083WA SM615350084WA SM615350085WA SM615370003WA SM615370020WA SM615370021WA SM615370018WA SM615370019WA SM616430042WA SM616430044WA SM615440001WA SM615350088WA SM615350089WA SM617110009WA SM616200002WA SM615440003WA SM616210001WA SM616210002WA SM616210003WA SM617030011WA SM617040005WA SM617040006WA SM617100069WA SM615510004WA SM615510005WA SM615510006WA SM616220020WA SM616220019WA SM616360005WA SM615370022WA SM615500004WA SM615500009WA SM615510001WA SM615510002WA SM616190014WA SM616190016WA SM616220007WA SM616220008WA SM616220012WA SM616220013WA SM616360022WA SM616440024WA SM616220001WA SM617070009WA SM617100014WA SM615510003WA SM616340044WA SM615370006WA SM615370008WA SM615370010WA SM615370011WA SM615370012WA SM615370005WA SM616370001WA SM616220021WA SM616220022WA SM616220025WA SM616240005WA SM616240006WA SM616320022WA SM616320023WA SM616430043WA SM615340070WA SM615370009WA SM615430001WA SM615370007WA SM616220023WA SM616220024WA SM615360005WA SM615440002WA SM616100038WA SM616150004WA SM616150005WA SM616150006WA SM616160009WA SM616330001WA SM616440023WA SM616440026WA SM617030012WA SM617030013WA SM617030014WA SM615500001WA SM615500016WA SM616340045WA SM615330048WA SM615480007WA SM615480009WA SM616330006WA SM616330007WA SM616330008WA SM616330009WA SM616330010WA SM617100061WA SM616440022WA SM615480006WA SM616150008WA SM615500012WA SM615490010WA SM615500013WA SM616240009WA SM616330018WA SM616100032WA SM616100034WA SM616100036WA SM616100037WA SM615440004WA SM617090008WA SM617040007WA SM616300003WA SM616300004WA SM617100067WA SM617100068WA SM615370002WA SM615370004WA SM615370014WA SM615370015WA SM615370016WA SM615370017WA SM615480008WA SM615480010WA SM615500011WA SM615500015WA SM616440011WA SM616440012WA SM616440013WA SM617110005WA SM617110006WA SM615440005WA SM615440006WA SM615440007WA SM616080005WA SM616100031WA SM616320025WA SM616420009WA SM615340071WA SM615350072WA SM615350075WA SM615350077WA SM615350078WA SM616080004WA SM616080006WA SM616190013WA SM615260034WA SM616160010WA SM616190015WA SM615370013WA SM615430005WA SM615500014WA SM616240003WA SM616240004WA SM616190002WA SM616190003WA SM616190004WA SM616230011WA SM616230012WA SM616230013WA SM616230014WA SM616230015WA SM616230016WA SM616230017WA SM616230018WA SM616230019WA SM616230020WA SM616410015MA SM616410016MA SM616410017MA SM616410018MA SM616410019MA SM616410020MA SM616410021MA SM616410022MA SM616430033MA SM616340034MA SM616340033MA SM616230004WA SM616230005WA SM617070007WA SM615460002WA SM616450005WA SM616010007WA SM616400025WA SM616280003WA SM616230007WA SM616280002WA SM616500005WA SM616500006WA SM616500007WA SM616500008WA SM616500009WA SM617110004WA SM616300007WA SM616300008WA SM616080001WA SM616080002WA SM616290026WA SM616290027WA SM616510012WA SM615480002WA SM616360016WA SM616420017WA SM616470009WA SM616480009WA SM617090003WA SM616470013WA SM617010129WA SM617070006WA SM616280001WA SM616360012WA SM616460063WA SM616470011WA SM617070002WA SM616340048WA SM616340046WA SM616450011WA SM617090009WA SM616360013WA SM617070022WA SM616270023WA SM616360015WA SM616420003WA SM616420004WA SM616430050WA SM617070001WA SM616100002WA SM616140001WA SM616460012WA SM617100009WA SM616270024WA SM616400024WA SM617090007WA SM616480008WA SM616230009WA SM616480011WA SM616230001WA SM716340041WA SM716340042WA SM616480010WA SM616470010WA SM616470005WA SM616470006WA SM616360007WA SM617100010WA SM616360014WA SM616320001WA SM616230010WA SM616470002WA SM616470008WA SM617100008WA SM616470003WA SM616290025WA SM617090005WA SM616160001WA SM616360006WA SM616340047WA SM616340051WA SM617070008WA SM616420007WA SM616470004WA SM616470007WA SM617010130WA SM617070005WA SM617090010WA SM617090018WA SM617090019WA SM617100011WA SM617100012WA SM617100013WA SM616140002WA SM616230006WA SM616270001WA SM616290024WA SM616450012WA SM616460013WA SM616480012WA SM617010131WA SM617100062WA SM616420005WA SM616420006WA SM617090006WA SM616470012WA SM616200011MA SM616340017MA SM616410010MA SM616410011MA SM617060101MA SM617060102MA SM617060103MA SM615340062WA SM616200001WA SM616480020WA SM616470001WA SM617100063WA SM617100064WA SM617060005WA SM617110007WA SM617110008WA SM617110015WA SM616230002WA SM616230003WA SM616480016WA SM617090001WA SM617090002WA SM617090004WA SM617090017WA SM617060125MA SM616190017WA SM616510013WA SM616510014WA SM616510015WA SM616510016WA SM616510017WA SM616510018WA SM616510019WA SM616330017WA SM616460003WA SM617110010WA SM616010008WA SM616480017WA SM616010002WA SM616010003WA SM616010004WA SM616010005WA SM616010006WA SM616160002WA SM616170015WA SM616290009WA SM616290010WA SM616290011WA SM616290012WA SM616290013WA SM616360001WA SM616360002WA SM616480013WA SM616480014WA SM616480015WA SM617040002WA SM617040003WA SM615490004WA SM616410042MA SM615520005WA SM615520006WA SM615520007WA SM616490002WA SM617060121MA SM617060122MA SM617060123MA SM617060124MA SM616410059MA SM616410060MA SM617060036MA SM617060037MA SM617060038MA SM617100017MA SM616460040MA SM616460041MA SM616460042MA SM616460043MA SM616460038MA SM616460039MA SM616460050MA SM616460051MA SM617060085MA SM617060086MA SM617060087MA SM616050001WA SM616100001WA SM616160011WA SM616160012WA SM616190012WA SM616450001WA SM616450002WA SM616460061WA SM616460062WA SM616020005WA SM617060092MA SM616310030MA SM616320004MA SM616320005MA SM616320006MA SM616320007MA SM616320008MA SM617010100MA SM617100153MA SM616170002WA SM616170004WA SM616400015MA SM617010101MA SM617010102MA SM615490005WA SM615490006WA SM615500006WA SM616050003WA SM616020001WA SM616290014WA SM615420001WA SM616410048MA SM616010001WA SM616280027MA SM616250008MA SM616250009MA SM616270003MA SM616270004MA SM616270005MA SM616270006MA SM616270007MA SM616270008MA SM616270009MA SM616270010MA SM616270011MA SM616270012MA SM616270013MA SM616270014MA SM616270015MA SM616270016MA SM616270017MA SM616270018MA SM616270019MA SM616270020MA SM616410003MA SM616410004MA SM616410005MA SM616410006MA SM616410007MA SM616410008MA SM616410009MA SM616250010MA SM616280026MA SM616340036MA SM616340037MA SM616340038MA SM616400006MA SM616430027MA SM616430028MA SM615430002WA SM615430003WA SM616100035WA SM616100039WA SM616100040WA SM616190006WA SM616190007WA SM616190008WA SM616190009WA SM616190010WA SM616190011WA SM616210023WA SM616210024WA SM616320027WA SM616320028WA SM616320029WA SM616320030WA SM616320031WA SM616320032WA SM616320033WA SM616320034WA SM616320035WA SM616320036WA SM616430047WA SM616430048WA SM616430049WA SM616440007WA SM616440008WA SM616440009WA SM616440010WA SM617030001WA SM617030002WA SM617030003WA SM617030004WA SM617030005WA SM617030006WA SM617030007WA SM617030008WA SM617030009WA SM617030010WA SM617020024MA SM617020025MA SM616050002WA SM616150003WA SM616200003WA SM616200004WA SM616380001WA SM616380002WA SM616380003WA SM616380004WA SM617020027WA SM616110004WA SM616110002WA SM616110003WA SM616440015WA SM615460001WA SM616110001WA SM616410001WA SM616460010WA SM616360021WA SM616360019WA SM616360020WA SM616380005WA SM616360023WA SM616480004WA SM616070004WA SM616360017WA SM616360018WA SM616440014WA SM616230021WA SM616280004WA SM616450004WA SM616460011WA SM616480005WA SM616480006WA SM616480007WA SM616480001WA SM616170017WA SM617100154MA SM615480001WA SM616490003WA SM616490004WA SM615380001WA SM615380002WA SM616290021WA SM616240010WA SM616510020WA SM616510021WA SM616100041WA SM616460014WA SM616460015WA SM616460016WA SM616460017WA SM616450010WA SM616070001WA SM616070002WA SM616420008WA SM617120001WA SM617120002WA SM617120003WA SM615480003WA SM615480004WA SM615490001WA SM615500010WA SM616100003WA SM616100004WA SM616240008WA SM616490001WA SM616360003WA SM616370004WA SM615480005WA SM616020002WA SM616240007WA SM616200017MA SM616310019MA SM616340024MA SM616340026MA SM616430029MA SM616430030MA SM616430031MA SM616430032MA SM616460018MA SM616460019MA SM617010103MA SM617010104MA SM617050005MA SM617050006MA SM617050007MA SM617050008MA SM617050040MA SM617060090MA SM617060091MA SM617060093MA SM617060094MA SM617060095MA SM617060096MA SM617060097MA SM617060104MA SM617060105MA SM617100156MA SM616200010MA SM616430040MA SM616320009MA SM616320010MA SM616320011MA SM617060088MA SM617060089MA SM616400002MA SM616400003MA SM617050001MA SM617050002MA SM617050003MA SM617050004MA SM616440016WA SM616440019WA SM616440020WA SM616440021WA SM616450013WA SM616460001WA SM616460002WA SM617090011WA SM617090012WA SM617090013WA SM617090014WA SM617090015WA SM617090016WA SM616290022WA SM616290023WA SM616420010WA SM616190001WA SM616200025WA SM616200026WA SM616200027WA SM616200028WA SM616200029WA SM616200030WA SM616450009WA SM616360004WA SM616360008WA SM616360009WA SM616360010WA SM616360011WA SM616220014WA SM616220015WA SM616220016WA SM616220017WA SM616220018WA SM616220026WA SM616220027WA SM616230008WA SM616480002WA SM616480003WA SM617120004WA SM617120005WA SM617070003WA SM617070004WA SM616440017WA SM616440018WA SM616320026WA SM717100065WA SM717100066WA SM616210005WA SM616210006WA SM616210007WA SM616210008WA SM616210009WA SM616210010WA SM616210011WA SM616210012WA SM616210013WA SM616210014WA SM616210015WA SM616210016WA SM616210017WA SM616210018WA SM616210019WA SM616210020WA SM616210021WA SM616210022WA SM616220002WA SM616220003WA SM616150009WA SM616370007WA SM616420011WA SM616420012WA SM616420013WA SM616420014WA SM616420015WA SM616420016WA SM617100015MA SM617100016MA SM615020004WA SM616170023MA SM616170024MA SM616170025MA SM616170026MA SM616170027MA SM616170028MA SM616170029MA SM616170030MA SM616200005MA SM616200006MA SM616200007MA SM616200008MA SM616200009MA SM616310013MA SM616310014MA SM616310015MA SM616310016MA SM616310017MA SM616310018MA SM616310020MA SM616310021MA SM616310022MA SM616310023MA SM616310024MA SM616310025MA SM616310026MA SM616310027MA SM616310028MA SM616320012MA SM616320013MA SM616320014MA SM616320015MA SM616320016MA SM616320017MA SM616320018MA SM616320019MA SM616320020MA SM616320021MA SM616340003MA SM616340004MA SM616340005MA SM616340006MA SM616340007MA SM616340008MA SM616340009MA SM616340010MA SM616340011MA SM616340012MA SM616340013MA SM616410049MA SM616410050MA SM616410051MA SM616410052MA SM616410053MA SM616410054MA SM616410055MA SM616410058MA SM616430001MA SM616430002MA SM616430003MA SM616430004MA SM616430005MA SM616430006MA SM616430007MA SM616430008MA SM616430009MA SM616430010MA SM616430011MA SM616430012MA SM616430013MA SM616430014MA SM616430015MA SM616430016MA SM616430017MA SM616430018MA SM616430019MA SM616430020MA SM616430021MA SM616430022MA SM616430023MA SM616430036MA SM616430037MA SM616430038MA SM616430039MA SM616460020MA SM616460021MA SM617010105MA SM617060106MA SM617060107MA SM617060108MA SM617060109MA SM617060110MA SM617060111MA SM617060112MA SM617060113MA SM617060114MA SM617060115MA SM617060116MA SM617060117MA SM617060118MA SM617060119MA SM617060120MA Carestation 650 A1: SM717020018MA SM717020019MA SM717020020MA SM717020021MA SM717020022MA SM717010103MA SM716300040MA SM716300041MA SM716300031MA SM716480059MA SM716480060MA SM716510010MA SM716510011MA SM716510012MA SM716510013MA SM716510014MA SM716380022MA SM716380023MA SM716380024MA SM716480021MA SM716480022MA SM716480023MA SM716480024MA SM716480025MA SM716480026MA SM716480027MA SM716480028MA SM717020026MA SM717020027MA SM717020028MA SM717020029MA SM717020030MA SM716510015MA SM716510016MA SM716510017MA SM717020040MA SM716300024MA SM716300025MA SM716300026MA SM716430052MA SM716430053MA SM716430054MA SM716430055MA SM716480057MA SM716480029MA SM716480030MA SM716480031MA SM716480032MA SM716480033MA SM716270006MA SM716270007MA SM717010115MA SM717010117MA SM717010118MA SM717010120MA SM717010121MA SM717010122MA SM717010123MA SM717010124MA SM717010125MA SM717010126MA SM717010127MA SM717010128MA SM717010129MA SM717010130MA SM717010131MA SM717010132MA SM717010133MA SM717010134MA SM717010135MA SM717010136MA SM717010137MA SM717010138MA SM717010139MA SM717010140MA SM717020039MA SM717100043MA SM717100044MA SM717100045MA SM717010116MA SM717010119MA SM716300027MA SM716480058MA SM717100047MA SM717100048MA SM717100049MA SM716480055MA SM717100042MA SM716200046MA SM716200047MA SM716430046MA SM717010109MA SM716310001MA SM716430066MA SM716430067MA SM716430068MA SM716390011MA SM716390012MA SM716270001MA SM717020047MA SM717020048MA SM716200033MA SM717010104MA SM716270008MA SM716250022MA SM716250023MA SM716430063MA SM716430064MA SM716430065MA SM716300032MA SM716300033MA SM716300034MA SM716300035MA SM716300036MA SM716300037MA SM716300038MA SM716430047MA SM717100039MA SM717100040MA SM716200048MA SM716200049MA SM716200050MA SM716250016MA SM716250017MA SM716250018MA SM717100041MA SM716100021MA SM716480056MA SM717020036MA SM716380017MA SM717020057MA SM716380015MA SM717080055MA SM716480045MA SM716480046MA SM716480047MA SM716480048MA SM716480049MA SM716480050MA SM716430050MA SM716430051MA SM716460006MA SM716460007MA SM716390006MA SM716390007MA SM716390008MA SM717020023MA SM717020024MA SM717020025MA SM716300044MA SM716300045MA SM716460023MA SM716460024MA SM716460025MA SM716460026MA SM716460027MA SM716460028MA SM716460029MA SM716460030MA SM716460031MA SM716460032MA SM716460033MA SM716460034MA SM716460035MA SM716460036MA SM716460037MA SM716460038MA SM716460039MA SM716460040MA SM716460041MA SM716460042MA SM716460063MA SM716460064MA SM716460065MA SM716460066MA SM716460067MA SM716460068MA SM716480034MA SM716480035MA SM716480036MA SM716300039MA SM717100046MA SM716460070MA SM717080060MA SM716100022MA SM716100023MA SM716100025MA SM716100026MA SM716100029MA SM716100030MA SM716100031MA SM716100032MA SM716100033MA SM716100034MA SM716100035MA SM716200042MA SM716380018MA SM716380019MA SM716380020MA SM716100027MA SM716100028MA SM716200032MA SM716200034MA SM716200035MA SM716200036MA SM716200037MA SM716200038MA SM716200039MA SM716200040MA SM716200041MA SM716200043MA SM716200044MA SM716250019MA SM716250020MA SM716430031MA SM716430033MA SM716430034MA SM716430035MA SM717100034MA SM716100024MA SM716430032MA SM716250021MA SM716300020MA SM716460010MA SM716460011MA SM716460012MA SM716460013MA SM716460014MA SM715500017WA SM716200002WA SM716200014WA SM716380016MA SM716390009MA SM716390010MA SM717020052MA SM717020053MA SM716350005WA SM716370037WA SM716230001WA SM716230002WA SM716230003WA SM716250001WA SM716250002WA SM716250003WA SM715440002WA SM715390003WA SM716420007WA SM716070001WA SM716320009WA SM716320010WA SM716290019WA SM716190026WA SM716450029WA SM716450030WA SM716450031WA SM716240001WA SM717060010WA SM716230012WA SM716420006WA SM716420008WA SM716460073WA SM716350004WA SM716290020WA SM715480019WA SM715480020WA SM715490012WA SM715490013WA SM715490014WA SM715490015WA SM716050005WA SM716330020WA SM716330021WA SM716340012WA SM716470006WA SM716470007WA SM716470008WA SM716470009WA SM716470010WA SM716470011WA SM716470012WA SM716490006WA SM716490007WA SM716490008WA SM716490009WA SM717020059WA SM717120001WA SM715360006WA SM715490019WA SM715490020WA SM716010009WA SM716030002WA SM716040005WA SM716040006WA SM716040007WA SM716040008WA SM716040009WA SM716040010WA SM716160001WA SM716240004WA SM716240005WA SM716240006WA SM716240007WA SM716240008WA SM716290014WA SM716290015WA SM716370010WA SM716440029WA SM716460020WA SM716460071WA SM716460072WA SM716490002WA SM716490003WA SM716490004WA SM717010145WA SM717100067WA SM717110023WA SM717110024WA SM717110025WA SM715360014WA SM715480021WA SM715480022WA SM715490001WA SM716010004WA SM716010005WA SM716160002WA SM716160003WA SM716160005WA SM716300028MA SM716300029MA SM716300030MA SM716430056MA SM716430057MA SM716430058MA SM716430059MA SM716430060MA SM715250029WA SM716360036WA SM716360014WA SM716290002WA SM716360015WA SM716360016WA SM716410011WA SM717020017WA SM717020058WA SM717120003WA SM716080021WA SM716290001WA SM716190024WA SM716280003WA SM716290003WA SM716360013WA SM716410001WA SM716410002WA SM716410003WA SM716410004WA SM716410005WA SM716410006WA SM716410007WA SM716410008WA SM716410009WA SM716410010WA SM716300054WA SM717060014WA SM717060015WA SM715490022WA SM715490023WA SM715380007WA SM717100036MA SM717080056MA SM717080057MA SM717080058MA SM717080059MA SM717100033MA SM716200045MA SM717020049MA SM716430070MA SM716270004MA SM717060030MA SM717060031MA SM717060032MA SM717060033MA SM717060034MA SM717060035MA SM717060036MA SM717060037MA SM716050013WA SM716080005WA SM716080007WA SM716160006WA SM716160007WA SM716160008WA SM716300042MA SM716300043MA SM716080014WA SM715350090WA SM715460011WA SM715460012WA SM716160009WA SM715360008WA SM715370002WA SM715370003WA SM715440003WA SM716050003WA SM716050004WA SM716050007WA SM716050009WA SM716050010WA SM716050011WA SM716190017WA SM716240020WA SM716240021WA SM716240022WA SM716240023WA SM716240024WA SM716280019WA SM716320014WA SM716330009WA SM716360009WA SM716360017WA SM716370012WA SM716370013WA SM716370014WA SM716370016WA SM716370017WA SM716370018WA SM716370021WA SM716370022WA SM716370023WA SM716370024WA SM716440019WA SM716440021WA SM717110026WA SM717110027WA SM717110028WA SM717110029WA SM717110030WA SM717110031WA SM717110032WA SM717110033WA SM717110034WA SM717110035WA SM715330050WA SM716050002WA SM716100036MA SM716080006WA SM715490018WA SM715490021WA SM716080002WA SM716080003WA SM716080004WA SM716210004WA SM716440002WA SM716350003WA SM716490001WA SM715420004WA SM716490020WA SM716450027WA SM716280020WA SM716280021WA SM715470001WA SM715470002WA SM716070004WA SM716070005WA SM717080064WA SM716280014WA SM716280017WA SM716280018WA SM717110008WA SM715430005WA SM715470020WA SM715480015WA SM716460017WA SM716220006WA SM716220005WA SM715420009WA SM716200017WA SM716340013WA SM716420013WA SM717060009WA SM717060019WA SM717020037MA SM717020038MA SM717060017WA SM717060018WA SM716450016WA SM716020008WA SM716290004WA SM716290005WA SM716460016WA SM716470001WA SM716460018WA SM716460019WA SM716090001WA SM716140004WA SM716190020WA SM716210002WA SM716210003WA SM716240044WA SM716240045WA SM716290021WA SM716300001WA SM717060016WA SM716370039WA SM715430006WA SM716190025WA SM715340056WA SM716050006WA SM716090002WA SM716140003WA SM716420014WA SM716420015WA SM716420016WA SM715420010WA SM715420011WA SM716160011WA SM716200015WA SM716200016WA SM716440032WA SM717040001WA SM717040002WA SM717040003WA SM717090007WA SM715500014WA SM716070008WA SM716200051WA SM716200052WA SM716200053WA SM716250013WA SM716250014WA SM716250015WA SM715270035WA SM716480064WA SM716440031WA SM715350073WA SM715350074WA SM716040001WA SM716040002WA SM716040003WA SM716040004WA SM716080008WA SM716260001WA SM716260002WA SM716080017WA SM716080018WA SM716080019WA SM716080020WA SM716460076WA SM716460077WA SM716010001WA SM716010002WA SM716190028WA SM715030009WA SM715280039WA SM715290047WA SM715330052WA SM715490027WA SM715500015WA SM715500016WA SM716070009WA SM716070010WA SM716070011WA SM716080001WA SM716240042WA SM716360007WA SM717010154WA SM717020008WA SM717020009WA SM717020010WA SM717090001WA SM716020004WA SM715270037WA SM715290046WA SM716190011WA SM716190012WA SM716500001WA SM716500002WA SM716500003WA SM716500004WA SM716500005WA SM716500006WA SM716500007WA SM716500008WA SM716500009WA SM716500012WA SM716500013WA SM716320011WA SM716320012WA SM716320013WA SM716240041WA SM716360010WA SM716300052WA SM716300053WA SM717090009WA SM715260032WA SM715280040WA SM716270011WA SM716410013WA SM716410014WA SM715260031WA SM715270036WA SM717060024WA SM716070007WA SM717010142WA SM715470004WA SM715470005WA SM715470006WA SM715470007WA SM715470008WA SM715470009WA SM715470010WA SM715470011WA SM715470012WA SM715470013WA SM715470014WA SM715470015WA SM715470016WA SM715470017WA SM715470018WA SM715470019WA SM715280038WA SM716070012WA SM
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.