FDA Device recall Z-1199-2018
DATEX-OHMEDA AISYS CS2 ALADIN2 CASSETTE Cassettes are intended to be used to deliver anesthetic agent
- FDA Device
- Class II
- terminated
- Published 2018-04-04
On 2018-04-04 the FDA classified a Class II recall of DATEX-OHMEDA AISYS CS2 ALADIN2 CASSETTE Cassettes are intended to be used to deliver anesthetic agent by Ge Healthcare, citing non-Conforming devices were shipped from the service center without proper evaluation and therefore may be nonconforming.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1199-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-10-04 |
| Published | 2018-04-04 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Ge Healthcare |
| Distribution | AZ, IL, NC, NH, PA |
Product
DATEX-OHMEDA AISYS CS2 ALADIN2 CASSETTE Cassettes are intended to be used to deliver anesthetic agent.
Reason
Non-Conforming devices were shipped from the service center without proper evaluation and therefore may be nonconforming.
Identifiers
| code_info | Model 1100-9034-000 Mfg. Lot or Serial # BGBQ00675 and BGBQ01187 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1199-2018%22
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