GE Healthcare, Aisys Carestation.
FDA Device Recall #Z-1382-2016 — Class II — February 17, 2016
Recall Summary
| Recall Number | Z-1382-2016 |
| Classification | Class II — Moderate risk |
| Date Initiated | February 17, 2016 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | GE Medical Systems, LLC |
| Location | Waukesha, WI |
| Product Type | Devices |
| Quantity | 1294 |
Product Description
GE Healthcare, Aisys Carestation.
Reason for Recall
GE Healthcare has recently become aware of a potential safety issue involving a momentary, self-correcting anesthetic agent bolus when using 21% oxygen on all Aisys CS2 and upgraded Aisys anesthesia devices.
Distribution Pattern
US: AL, AZ, AR, CA, CO, DC, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MO, NE, NV, NJ, NY, NC, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI. OUS: ARGENTINA, AUSTRALIA, AUSTRIA, BAHRAIN, BELGIUM, BERMUDA, BOLIVIA, BRAZIL, CANDA, CHILE, CHINA, COLOMBIA, CROATIA, CR¿CHE REPUBLIC, DENMARK, ESTONIA, FINLAND, FRANCE, GERMANY,GREECE, HELSINKI, HONG KONG, HUNGARIA, ICELAND, INDIA, IRAQ, IRELAND, ITA LY, JAPAN, JORDAN, KAZAKHSTAN, KOREA, KUWAIT, MALAYSIA, MEXICO, MOLDOVA, MOROCCO, NETHERLANDS, NEW CALEDONIA, NEW ZEALAND, NORWAY, PERU, POLAND, PORTUGAL QATAR, REUNION, ROMANIA, RUSSIAN FEDERATION, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SOUTH AFRICA, SPAIN, SWEDEN SWITZERLAND, TAIWAN, TANZANIA, THAILAND, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM,URUGUAY, VIETNAM.
Lot / Code Information
ANAS00632 ANAR00333 ANAR00334 ANAR05370 ANAR05371 ANAR05372 TOUCHSCREEN DISPLAY Kits (Each to be instaleed in device. Device serial number to be provided later) 5395419-1 5395419-2 5395419-3 5405365 5391200-1 5391200-10 5391200-11 5391200-12 5391200-2 5391200-3 5391200-4 5391200-5 5391200-6 5391200-7 5391200-8 5391200-9 5402182 5393755-1 5393755-2 5403569-1 5403569-10 5403569-11 5403569-12 5403569-13 5403569-2 5403569-3 5403569-4 5403569-5 5403569-6 5403569-7 5403569-8 5403569-9 5403570-1 5403570-2 5403570-3 5403570-4 5403570-5 5392643-1 5392643-10 5392643-11 5392643-12 5392643-13 5392643-2 5392643-3 5392643-4 5392643-5 5392643-6 5392643-7 5392643-8 5392643-9 5393856-1 5393856-10 5393856-11 5393856-12 5393856-13 5393856-14 5393856-15 5393856-2 5393856-3 5393856-4 5393856-5 5393856-6 5393856-7 5393856-8 5393856-9 5404595-1 5404595-10 5404595-11 5404595-12 5404595-13 5404595-14 5404595-15 5404595-16 5404595-17 5404595-18 5404595-19 5404595-2 5404595-3 5404595-4 5404595-5 5404595-6 5404595-7 5404595-8 5404595-9 5404596-1 5404596-2 5404596-3 5404596-4 5404596-5 5392846-1 5392437-1 5392437-2 5392437-3 5392437-4 5400852-1 5400852-10 5400852-11 5400852-12 5400852-2 5400852-3 5400852-4 5400852-5 5400852-6 5400852-7 5400852-8 5400852-9 5399939 5393121-1 5395521-1 5395521-2 5394120-1 5394120-2 5394120-3 5394120-4 5394120-5 5394120-6 5394120-7 5401872-1 5401872-2 5401872-3 5401872-4 5391217-1 5391217-2 5391217-3 5391217-4 5391217-5 ANAS00222 ANAS00223 ANAS01491 ANAS01492 ANAS01493 ANAS01494 ANAS01495 ANAS01496 ANAS01497 ANAS01498 ANAS01499 ANAS01500 ANAS01501 5403246-1 5403246-2 5403246-3 5402722-1 5402722-2 5402722-3 5402722-4 5402722-5 5402722-6 5402198-1 5402198-2 5402198-3 5401596-1 5401596-2 5401596-3 5398908-1 5398908-10 5398908-11 5398908-12 5398908-13 5398908-14 5398908-15 5398908-16 5398908-17 5398908-18 5398908-19 5398908-2 5398908-20 5398908-21 5398908-22 5398908-23 5398908-24 5398908-25 5398908-26 5398908-27 5398908-28 5398908-29 5398908-3 5398908-30 5398908-31 5398908-32 5398908-33 5398908-34 5398908-35 5398908-36 5398908-37 5398908-38 5398908-39 5398908-4 5398908-40 5398908-41 5398908-42 5398908-43 5398908-44 5398908-45 5398908-46 5398908-47 5398908-48 5398908-49 5398908-5 5398908-6 5398908-7 5398908-8 5398908-9 5398909-1 5398909-10 5398909-2 5398909-3 5398909-4 5398909-5 5398909-6 5398909-7 5398909-8 5398909-9 5394339-1 5394339-2 5394339-3 5394339-4 5394339-5 ANAT00289 ANAT00290 ANAT00291 ANAT00292 ANAT00293 ANAT00294 ANAK 00930 ANAK00927 ANAK00928 ANAK00929 ANAK00931 ANAK00932 ANAK00933 ANAK00934 ANAK00935 ANAK00936 ANAK00937 ANAP00607 ANAP00608 ANAQ00896 ANAQ00897 ANAQ00898 ANAQ00899 5393947-1 5393947-10 5393947-11 5393947-12 5393947-13 5393947-14 5393947-15 5393947-16 5393947-17 5393947-18 5393947-19 5393947-2 5393947-20 5393947-21 5393947-22 5393947-23 5393947-24 5393947-25 5393947-26 5393947-27 5393947-28 5393947-29 5393947-3 5393947-30 5393947-31 5393947-32 5393947-33 5393947-34 5393947-35 5393947-36 5393947-37 5393947-38 5393947-39 5393947-4 5393947-40 5393947-41 5393947-42 5393947-43 5393947-44 5393947-45 5393947-46 5393947-5 5393947-6 5393947-7 5393947-8 5393947-9 5400501-1 5400501-2 5400501-3 5391726-1 5391726-2 5391726-3 5391726-4 5391726-5 5391726-6 5391726-7 5391726-8 5391984-1 5391984-10 5391984-11 5391984-12 5391984-2 5391984-3 5391984-4 5391984-5 5391984-6 5391984-7 5391984-8 5391984-9 5396748-1 5396748-2 5386407-1 5386407-10 5386407-11 5386407-12 5386407-13 5386407-14 5386407-15 5386407-16 5386407-17 5386407-18 5386407-19 5386407-2 5386407-20 5386407-21 5386407-22 5386407-23 5386407-24 5386407-3 5386407-4 5386407-5 5386407-6 5386407-7 5386407-8 5386407-9 5402754-1 5402754-2 5402754-3 5402754-4 5391031-1 5391031-10 5391031-11 5391031-12 5391031-2 5391031-3 5391031-4 5391031-5 5391031-6 5391031-7 5391031-8 5391031-9 5385058-1 5385058-2 5385058-3 5385058-4 5385058-5 5385058-6 5385177-1 5385177-2 5385177-3 5385177-4 5385177-5 5385177-6 5385177-7 5385178-1 5385178-2 5385178-3 5385178-4 5385178-5 5385178-6 5385178-7 5385178-8 5385179-1 5385179-2 5385179-3 5385179-4 5385179-5 5385179-6 5385179-7 5400253 ANAR05242 ANAR05243 ANAR05244 ANAR05245 ANAR05246 ANAR05247 ANAR05248 ANAR05249 ANAR05250 ANAR05251 ANAR05252 ANAR05253 ANAR05254 ANAM01295 ANAP01379 ANAP01380 ANAP01381 ANAR00105 ANAR00106 ANAR00107 ANAR00108 ANAR00109 ANAR01033 ANAR05278 ANAR05279 ANAR05669 ANAR05670 ANAR05671 ANAR05672 ANAR05673 ANAQ01630 ANAS00270 ANAS00271 ANAS00272 ANAS00273 ANAS00274 ANAS00303 ANAS00304 ANAS00305 ANAS00306 ANAS00307 ANAS00308 ANAS00309 5394645-6 5394645-7 5394645-8 5394659-1 5395869-1 5397158-1 ANAS00345 ANAR00801 ANAR05674 ANAR05675 ANAR05676 ANAR05677 ANAR05678 ANAR05679 ANAS01116 ANAS01120 ANAS00871 ANAS00872 ANAS00873 ANAS00874 ANAS00875 ANAS00876 ANAR00776 ANAR00777 ANAR00778 ANAR00779 ANAR00780 ANAR00781 ANAR00782 ANAR00783 ANAR00784 ANAR00785 ANAR00786 ANAR00787 ANAR00788 ANAR00789 ANAR00790 ANAR00791 ANAR00792 ANAR00793 ANAR00794 ANAR00795 ANAR05378 ANAR05379 ANAR05381 ANAR05382 ANAR05383 ANAR05384 ANAR05385 ANAR05386 ANAR05387 ANAR05388 ANAR05389 ANAR05390 ANAR05391 ANAR05440 ANAR05441 ANAR05442 ANAR05443 ANAR05444 ANAR05445 ANAR05446 ANAR05447 ANAR05448 ANAR05449 ANAR05450 ANAR05451 ANAR05452 ANAR05453 ANAR05454 ANAR05455 ANAR05456 ANAR05457 ANAR05458 ANAR05459 ANAR05460 5399890-1 5399890-2 5399890-3 5399890-4 5399890-5 5399890-6 ANAS00469 ANAS00470 ANAS00471 ANAS00472 ANAS00473 ANAS00474 ANAR05277 ANAR05280 ANAR05281 ANAR05282 ANAR05283 ANAR05663 ANAR05664 ANAR05665 ANAR05666 ANAR05667 ANAR05668 ANAS01114 ANAS01115 ANAS01117 ANAS01118 ANAS01119 ANAS01121 ANAR00916 ANAR00917 ANAR00918 ANAR00919 ANAR00920 ANAR00921 ANAR00922 ANAR00923 5401591-1 5401591-2 5401591-3 5401673-1 5401673-10 5401673-11 5401673-12 5401673-13 5401673-14 5401673-15 5401673-16 5401673-2 5401673-3 5401673-4 5401673-5 5401673-6 5401673-7 5401673-8 5401673-9 5403035-1 5403035-2 5391329-1 5391328-1 5391666-1 5391666-2 5391666-3 5391666-4 5386597-1 5386597-2 5386597-3 5386597-4 5386597-5 5386597-6 5388856-1 5388856-2 5388856-3 5388856-4 5389018-1 5385679-1 5385679-2 5385679-3 5385679-4 5385679-5 5385679-6 5385679-7 5385679-8 5385679-9 5400474-1 5400474-2 5402055-1 5402055-2 5394314-1 5394314-2 5394314-3 5394314-4 5394314-5 5394314-6 5394314-7 5388388-1 5388388-2 5389296-1 5389296-2 5391526-1 5391526-2 5388857-1 5388857-2 5389020-1 5389020-2 5389019-1 5394888-1 5394888-2 5394888-3 5394888-4 5402930 5393292-1 5393292-2 5393292-3 5393292-4 5393292-5 5393292-6 5393292-7 5393292-8 5392267-1 5392267-10 5392267-2 5392267-3 5392267-4 5392267-5 5392267-6 5392267-7 5392267-8 5392267-9 5395278-1 5395278-2 5395278-3 5400173-1 5400173-2 5402534-1 5402534-2 5402534-3 5391401-1 5391401-2 5391401-3 5391401-4 5391401-5 5391401-6 5391401-7 5391401-8 5391401-9 5399799 5397127-1 5394404-1 5390533-1 5390533-2 5390533-3 5390533-4 5395211-1 5389501-1 5389501-10 5389501-11 5389501-12 5389501-13 5389501-14 5389501-2 5389501-3 5389501-4 5389501-5 5389501-6 5389501-7 5389501-8 5389501-9 5404504-1 5404504-2 5404504-3 5404504-4 5389972-1 5389972-2 5389972-3 5389972-4 5389972-5 5389972-6 5397310-1 5397310-2 5395528-1 ANAR00346 ANAR00347 ANAN00339 ANAP01444 ANAR00110 5391499-1 5388640-1 5388640-2 5388640-3 5388640-4 5388554-1 5388554-10 5388554-11 5388554-12 5388554-13 5388554-14 5388554-15 5388554-16 5388554-17 5388554-2 5388554-3 5388554-4 5388554-5 5388554-6 5388554-7 5388554-8 5388554-9 5384143-1 5384143-10 5384143-11 5384143-12 5384143-13 5384143-14 5384143-2 5384143-3 5384143-4 5384143-5 5384143-6 5384143-7 5384143-8 5384143-9 5388552-1 5388552-2 5388552-3 5388552-4 5388552-5 5396277-1 5396277-10 5396277-11 5396277-12 5396277-13 5396277-14 5396277-15 5396277-16 5396277-2 5396277-3 5396277-4 5396277-5 5396277-6 5396277-7 5396277-8 5396277-9 5388553-1 5388553-10 5388553-11 5388553-12 5388553-13 5388553-14 5388553-15 5388553-16 5388553-17 5388553-18 5388553-19 5388553-2 5388553-20 5388553-21 5388553-22 5388553-23 5388553-24 5388553-25 5388553-3 5388553-4 5388553-5 5388553-6 5388553-7 5388553-8 5388553-9 5388551-1 5388551-2 5388551-3 5388551-4 5388551-5 5388551-6 5388551-7 5389467-1 5389467-2 5389467-3 5385033-1 5385033-10 5385033-11 5385033-12 5385033-13 5385033-14 5385033-15 5385033-16 5385033-17 5385033-18 5385033-19 5385033-2 5385033-20 5385033-21 5385033-22 5385033-23 5385033-24 5385033-25 5385033-26 5385033-27 5385033-28 5385033-29 5385033-3 5385033-30 5385033-31 5385033-32 5385033-33 5385033-34 5385033-35 5385033-36 5385033-37 5385033-38 5385033-39 5385033-4 5385033-40 5385033-5 5385033-6 5385033-7 5385033-8 5385033-9 5390745-1 5391065-1 5391065-2 5392139-1 5392139-2 5392139-3 5392139-4 5392139-5 ANAJ00124 ANAK00470 ANAQ00221 ANAQ00222 ANAQ00223 ANAQ00232 ANAQ00233 ANAQ00234 ANAQ00235 ANAQ00236 ANAQ00237 ANAQ00238 ANAQ00239 ANAQ00240 ANAQ00241 ANAQ00242 ANAQ00243 ANAQ00244 ANAQ00245 ANAQ00246 ANAQ00247 ANAQ00476 ANAQ00477 ANAQ00478 ANAQ00479 ANAQ00480 ANAQ00481 ANAQ00482 ANAQ00483 ANAQ01078 ANAQ01079 ANAQ01080 ANAQ01081 ANAQ01082 ANAQ01470 ANAQ01471 ANAQ01669 ANAQ01670 ANAR00387 ANAR00388 ANAR00389 ANAR00390 ANAR00391 ANAR00392 ANAR00393 ANAR05116 ANAS00208 ANAS00209 ANAS00210 5400535 5399387-1 5399387-2 5399387-3 5399387-4 5399387-5 ANAS00946 ANAS00947 ANAS00948 ANAS00949 ANAS00954 ANAS00955 ANAS00956 ANAS00957 5409690-1 5409690-2 5412287 5406361-1 5406361-10 5406361-11 5406361-12 5406361-13 5406361-14 5406361-15 5406361-16 5406361-17 5406361-18 5406361-19 5406361-2 5406361-3 5406361-4 5406361-5 5406361-6 5406361-7 5406361-8 5406361-9 5409858-4 5409858-5 5409858-6 5406068-1 5406068-2 5405877-1 5405877-10 5405877-11 5405877-12 5405877-13 5405877-14 5405877-15 5405877-2 5405877-3 5405877-4 5405877-5 5405877-6 5405877-7 5405877-8 5405877-9 5410240-1 5410240-2 5410240-3 5410240-4 540708710 5406028-1 5406028-10 5406028-11 5406028-12 5406028-13 5406028-14 5406028-2 5406028-3 5406028-4 5406028-5 5406028-6 5406028-7 5406028-8 5406028-9 5406580-1 5406580-10 5406580-11 5406580-12 5406580-13 5406580-14 5406580-15 5406580-16 5406580-17 5406580-2 5406580-3 5406580-4 5406580-5 5406580-6 5406580-7 5406580-8 5406580-9 5406581-1 5406581-10 5406581-11 5406581-12 5406581-13 5406581-14 5406581-15 5406581-16 5406581-17 5406581-18 5406581-19 5406581-2 5406581-3 5406581-4 5406581-5 5406581-6 5406581-7 5406581-8 5406581-9 5406582-1 5406582-2 5406582-3 5406582-4 5406582-5 5406582-6 5406582-7 5406583-1 5406583-2 5406583-3 5407087-1 5407087-11 5407087-12 5407087-2 5407087-3 5407087-4 5407087-5 5407087-6 5407087-7 5407087-8 5407087-9 5409944-1 5409944-2 5410042-1 5410042-10 5410042-11 5410042-12 5410042-13 5410042-14 5410042-15 5410042-16 5410042-17 5410042-2 5410042-3 5410042-4 5410042-5 5410042-6 5410042-7 5410042-8 5410042-9 5410044-1 5410044-10 5410044-11 5410044-12 5410044-13 5410044-14 5410044-15 5410044-16 5410044-17 5410044-2 5410044-3 5410044-4 5410044-5 5410044-6 5410044-7 5410044-8 5410044-9 5411892-1 5411892-2 5411892-3 5411892-4 5411892-5 5411892-6 5411892-7 5411892-8 5405287-1 5405287-2 5405824-1 5405824-10 5405824-11 5405824-12 5405824-13 5405824-14 5405824-15 5405824-16 5405824-17 5405824-18 5405824-19 5405824-2 5405824-20 5405824-21 5405824-22 5405824-23 5405824-24 5405824-25 5405824-26 5405824-27 5405824-28 5405824-29 5405824-3 5405824-30 5405824-31 5405824-32 5405824-33 5405824-34 5405824-35 5405824-36 5405824-37 5405824-38 5405824-39 5405824-4 5405824-40 5405824-5 5405824-6 5405824-7 5405824-8 5405824-9 540883410 5408834-1 5408834-11 5408834-12 5408834-13 5408834-14 5408834-15 5408834-16 5408834-17 5408834-18 5408834-2 5408834-3 5408834-4 5408834-5 5408834-6 5408834-7 5408834-8 5408834-9 5408683-1 5408683-2 ANAS01504 ANAS01505 ANAS01506 ANAS01507 ANAS01508 ANAS01509 ANAS01510 ANAS01511 ANAS01512 ANAS01513 5403110-1 5403110-2 5403110-3 5408134-1 5408134-2 5408134-3 5408134-4 5406128 5406853 5409815-1 5409815-2 5409815-3 5407339 5412076-1 5412076-10 5412076-11 5412076-2 5412076-3 5412076-4 5412076-5 5412076-6 5412076-7 5412076-8 5412076-9 5405018 5405019 5409995 5408906-1 5408906-2 5408906-3 5408906-4 5408906-5 5410237-1 5410237-2 5408321-1 5408321-2 5408321-3 5408321-4 5408321-5 5412310-1 5412310-2 5408050 5405424-1 5405424-2 5405424-3 5405424-4 5405424-5 5406620-1 5406620-2 5406620-3 5406620-4 5409115-1 5409115-2 5409115-3 5409115-4 5409115-5 5409115-6 5409115-7 5409115-8 5409132-1 5409132-2 5409132-3 5409132-4 5409132-5 5409132-6
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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.