Merge HEMO software recallZ-2341-2016 · Merge Healthcare, Inc. · initiated Jul 2, 2012
Class II Terminated All recalls posted in August 2016
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 International Normalized Ratio (INR) value displayed in the study report does not match the value that is imported on the pre-procedure labs screen from HL7
FDA root cause category: Software design
What the company is doing
The firm issued an "Important Product Information" bulletin to customers dated 7/2/2012 via e-mail letting them know there was an upgrade available. On 1/30/2016, the recalling firm initiated phone calls to their customers letting them know there was an upgrade available and if they declined it, they would like a written response.
Recall details
- Recall number
- Z-2341-2016
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Jul 2, 2012
- Posted by the FDA
- Aug 4, 2016
- Recalling firm
- Merge Healthcare, Inc.
- Quantity
- 37
- Product code
- DQK
- FDA submissions
- K082421
- Distribution
- The medical facilities who currently have the affected versions are located nationwide. There was government distribution but no military or foreign distribution.
Product description
Merge HEMO software.
Code information (models, lots, serial numbers)
Software versions 8.10, 9.10, 9.20.
Other devices under the same FDA submission
1 device cleared under K082421 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Merge Hemo 10.0.4Merge Healthcare Solutions Inc. · Computer, Diagnostic, Programmable11 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 18, 2026. Text above is shown as published by the FDA.
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