FDA-Device2023-06-21Class III
Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Model Number 0998-00-0800-55, Part Number 0998-00-0800-XX
Datascope Corp.
Hazard
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.
Sold states
International distribution in the country of Germany.
Affected count
4 units
Manufactured in
1300 Macarthur Blvd, N/A, Mahwah, NJ, United States
Products
Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Model Number 0998-00-0800-55, Part Number 0998-00-0800-XX
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1907-2023Don't want to check this manually?
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