GE Healthcare — Class II medical device recall Z-1382-2016
Terminated recall by GE Medical Systems, LLC, reported 2016-04-20, distributed in AL, AR, AZ, CA, CO, DC, FL, GA…. GE Healthcare has recently become aware of a potential safety issue involving a momentary, self-correcting ane
| Recall number | Z-1382-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Medical Systems, LLC, Waukesha, WI, United States |
| Recall initiated | 2016-02-17 |
| Classified | 2016-04-13 |
| Reported by FDA | 2016-04-20 |
| Terminated | 2018-09-04 |
| Distributed | AL, AR, AZ, CA, CO, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, NC, NE, NJ, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI |
| Countries outside the US | AE, AR, AT, AU, BE, BH, BM, BO, BR, CH, CL, CN, CO, DE, DK, EE, ES, FI, FR, GB, GR, HK, HR, IE, IN, IQ, IS, JO, JP, KR, KW, MA, MX, MY, NL, NO, NZ, PE, PL, PT, QA, RO, SA, SE, SG, SK, TH, TR, TW, UY, VN, ZA |
| Quantity | 1,294 |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1382-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.