Recall Z-2387-2021— Merge Healthcare, Inc.
Class II · Terminated
Class II FDA medical device recall by Merge Healthcare, Inc., initiated 2021-07-23, terminated 2023-08-29. It names one FDA 510(k) clearance: K152864. Product: Merge Hemo, Software packages 10.2, 10.3, and 10.4. Reason: 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..
- Recalling firm
- Merge Healthcare, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-07-23
- Terminated
- 2023-08-29
- Firm location
- Hartland, WI, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.