FDA recall Z-2387-2021
Merge Healthcare, Inc. · Class II · device
Product
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
US distribution
Key facts
- Status
- Terminated
- Initiation date
- 2021-07-23
- Report date
- 2021-09-08
- Termination date
- 2023-08-29
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Hartland, WI, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2387-2021