Device product
Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Model Number 0998-00-0800-55, Part Number 0998-00-0800-XX
Z-1907-2023
Product summary
- Firm
- Datascope Corp.
- Event
- Event 92214
- Status
- Ongoing
- Classification
- Class III
- Quantity
- 4 units
- Official record key
device-enforcement:Z-1907-2023
Official wording
Reason: The digital IFUs provided with the Cardiosave IABP during the software update to version D.00 incorrectly annotated compliance to standard 60601-1-12:2014 within the updated IFU.
Code information: UDI-DI: 10607567108414; Serial Numbers: CB286971I8 CB283804G8 CB283867G8 CB283522G8
Distribution pattern: International distribution in the country of Germany.
Derived failure modes
-
Unknown
The digital IFUs provided with the Cardiosave IABP during the software update to version D.00 incorrectly annotated compliance to standard 60601-1-12:2014 within the updated IFU.