Recall Z-2387-2021
Merge Healthcare, Inc. · initiated July 23, 2021
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Merge Hemo, Software packages 10.2, 10.3, and 10.4
Codes / lots: Version 10.2, UDI (01)00842000100430(10)10.2(11)190612 Version 10.3, UDI (01)00842000100874(10)10.3(11)200330 Version 10.4, UDI (01)00842000100966(10)10.4(11)210428
Reason for recall
The firm identified a safety issue affecting the software associated with Merge Hemo versions 9.x and 10.x, used in combination with an HL7 lab interface.
FDA-determined cause: Under Investigation by firm
Action taken
The firm issued an Urgent Field Safety Notice by email on 07/23/2021. The letter explained the issue and provided a workaround for the safe, continued use of the instrument until a software correction can be made.
Details
- Recall number
- Z-2387-2021
- Initiated
- July 23, 2021
- Terminated
- August 29, 2023
- Product code
- DQK – Computer, Diagnostic, Programmable
- Quantity
- 326 units
- Distribution
- US distribution
- Recalling firm
- Merge Healthcare, Inc., Hartland, WI