Company: Datascope Corp.
Date of Enforcement Report: 06/14/2023
Class III
PRODUCT
Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Model Number 0998-00-0800-55, Part Number 0998-00-0800-XX
Recall Number:
Z-1907-2023
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.
RECALLING FIRM/MANUFACTURER:
Datascope Corp.
VOLUME OF PRODUCT IN COMMERCE:
4 units
DISTRIBUTION:
International distribution in the country of Germany.
