GE Healthcare Avance CS2 — Class II medical device recall Z-1427-2022
Ongoing recall by GE Healthcare, LLC, reported 2022-07-27, distributed in AZ, CA, CO, CT, FL, IA, ID, IL…. The base of the anesthesia system can have a crack and could potentially fracture resulting in a tip or overba
| Recall number | Z-1427-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, LLC, Waukesha, WI, United States |
| Recall initiated | 2022-05-27 |
| Classified | 2022-07-20 |
| Reported by FDA | 2022-07-27 |
| Distributed | AZ, CA, CO, CT, FL, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MO, MT, NC, NE, NV, NY, OH, PA, SC, TN, TX, VA, WV |
| Countries outside the US | AE, AU, CA, CH, CN, DE, EE, FI, FR, GB, GR, ID, IE, IN, IQ, IT, JO, JP, KE, KR, MY, NZ, PH, RO, RU, SA, TR, TW, VN |
| Quantity | 667 devices |
| Reason classes | packaging, device malfunction |
| UPC / GTIN / UDI-DI | 00840682102292, 00840682102322 |
| Model numbers | 1009-9050-000, 1011-9050-000 |
Product
GE Healthcare Avance CS2, Avance CS2 Pro Anesthesia Systems, Part #1009-9050-000; and Aisys CS2 Anesthesia Systems, Part # 1011-9050-000.
Reason for recall
The base of the anesthesia system can have a crack and could potentially fracture resulting in a tip or overbalance of the anesthesia system. This can result in potential injury if it falls on a person.
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-1427-2022. 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.