Device product
DATEX-OHMEDA AISYS CS2 ALADIN2 CASSETTE Cassettes are intended to be used to deliver anesthetic agent.
Z-1199-2018
Product summary
- Event
- Event 79493
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2
- Official record key
device-enforcement:Z-1199-2018
Official wording
Reason: Non-Conforming devices were shipped from the service center without proper evaluation and therefore may be nonconforming.
Code information: Model 1100-9034-000 Mfg. Lot or Serial # BGBQ00675 and BGBQ01187
Distribution pattern: US Distribution to states of: AZ, IL NC, NH and PA.
Derived failure modes
-
Unknown
Non-Conforming devices were shipped from the service center without proper evaluation and therefore may be nonconforming.