Z-2387-2021 Class II Terminated
FDA device recall Z-2387-2021 was initiated by Merge Healthcare, Inc. on July 23, 2021 and is designated Class II. 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. The recall status is terminated (terminated August 29, 2023). Affected quantity: 326 units.
Recall Details
- Product Type
- Devices
- Report Date
- September 8, 2021
- Initiation Date
- July 23, 2021
- Termination Date
- August 29, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 326 units
Product Description
Merge Hemo, Software packages 10.2, 10.3, and 10.4
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 Pattern
US distribution
Code Information
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