Merge Hemo recallZ-2387-2021 · Merge Healthcare, Inc. · initiated Jul 23, 2021
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Merge Healthcare, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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 root cause category: Under Investigation by firm
What the company is doing
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.
Recall details
- Recall number
- Z-2387-2021
- Status
- Terminated
- Initiated by the company
- Jul 23, 2021
- Recalling firm
- Merge Healthcare, Inc.
- Quantity
- 326 units
- Product code
- DQK
- FDA submissions
- K152864
- Distribution
- US distribution
Product description
Merge Hemo, Software packages 10.2, 10.3, and 10.4
Code information (models, lots, serial numbers)
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
Devices named in this recall
3 devices in the FDA device registry whose identifier appears in the recall's code information.
- Merge Hemo 10.4Merge Healthcare Solutions Inc. · Computer, Diagnostic, Programmable1 recall14 reports
- Merge Hemo 10.2Merge Healthcare Solutions Inc. · Computer, Diagnostic, Programmable1 recall3 reports
- Merge Hemo 10.3Merge Healthcare Solutions Inc. · Computer, Diagnostic, Programmable1 recall1 report
Product lines
Other devices under the same FDA submission
1 device cleared under K152864 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- Merge HEMO 10.1Merge Healthcare Solutions Inc. · Computer, Diagnostic, Programmable4 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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