DATEX-OHMEDA AISYS CS2 ALADIN2 CASSETTE Cassettes are intended to be… — Class II medical device recall Z-1199-2018
Terminated recall by GE Healthcare, LLC, reported 2018-04-04, distributed in AZ, IL, NC, NH, PA. Non-Conforming devices were shipped from the service center without proper evaluation and therefore may be non
| Recall number | Z-1199-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, LLC, Waukesha, WI, United States |
| Recall initiated | 2017-10-04 |
| Classified | 2018-03-26 |
| Reported by FDA | 2018-04-04 |
| Terminated | 2020-04-10 |
| Distributed | AZ, IL, NC, NH, PA |
| Quantity | 2 |
| Serial numbers | BGBQ00675, BGBQ01187 |
| Model numbers | 1100-9034-000 |
Product
DATEX-OHMEDA AISYS CS2 ALADIN2 CASSETTE Cassettes are intended to be used to deliver anesthetic agent.
Reason for recall
Non-Conforming devices were shipped from the service center without proper evaluation and therefore may be nonconforming.
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-1199-2018. 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.