Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Model Number 0998-00-0800-55, Part Number 0998-00-0800-XX
FDA device recall Z-1907-2023 · posted 2023-06-14 · Open, Classified
Recall details
- Recalling firm
- Datascope Corp.
- Reason for recall
- 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.
- Action taken
- An URGENT FIELD SAFETY NOTICE MEDICAL DEVICE CORRECTION notification letter was sent to customer on 5/4/23. Actions to be taken by the customer: " Please locate the CARDIOSAVE Hybrid IABPs with the serial numbers listed in this notice. " Please ensure that all Cardiosave Hybrid Intra-Aortic Balloon Pump users at your facility are aware of this notice. " Please forward this information to all current and potential Cardiosave Hybrid IABPs users within your hospital / facility. " Please contact your local Getinge Service Representative to arrange to have the affected IFU USB drives replaced. " Please complete and sign the attached URGENT FIELD SAFETY NOTICE RESPONSE FORM (page 3) to acknowledge that you have received this notification. Return the completed form to Datascope Corp./Getinge by e-mailing a scanned copy to fieldaction@getinge.com Actions to be taken by Getinge: Getinge will provide your facility with an updated IFU USB drive that contains reference to the vibration testing standard, 60601-1-12:2014. The original USB drive that was provided during the D.00 software update can be destroyed locally. This voluntary correction notification only affects the products listed on page 1; no other products are affected by this voluntary correction. We apologize for any inconvenience this Medical Device Correction may cause. If you have any questions, please contact your Datascope Corp./Getinge representative.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- DSP
- Quantity affected
- 4 units
- Distribution
- International distribution in the country of Germany.
- Date initiated
- 2023-05-04
- Date posted
- 2023-06-14
- Location
- Mahwah, NJ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP (K112372) | Cardiac Assist, Maquet Cardiovascular, LLC | 2011-09-15 |