Merge Hemo, Software packages 10.2, 10.3, and 10.4
This recall has been terminated (originally issued July 23, 2021).
- Company
- Merge Healthcare, Inc.
- Recall Initiated
- July 23, 2021
- Terminated
- August 29, 2023
- Recall Number
- Z-2387-2021
- Quantity
- 326 units
- Firm Location
- Hartland, WI
- Official Source
- View on FDA website ↗
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.
Distribution
US distribution
Lot / Code Info
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
Root 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.
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