Merge Hemo software. The firm name on the labeling is… recallZ-1778-2017 · Merge Healthcare, Inc. · initiated Apr 4, 2016
Class II Terminated All recalls posted in April 2017
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
Use of the software may show an incorrect value to the user when viewing the Fractional Flow Reserve (FFR) results during recording.
FDA root cause category: Software design
What the company is doing
MERGE sent an Urgent Medical Device Recall letter dated April 4, 2016 to all affected customers via e-mail the week of April 4, 2016. If no email address was available, the letters were issued via certified mail. A second letter dated July 11, 2016 was issued to non-responders. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to ensure that all users of the affected product be provided with the notice. Customers were also asked to reply using the enclosed form and the return addressed envelope. Customers with questions were instructed to send an email to [email protected]. For questions regarding this recall call 877-741-5369.
Recall details
- Recall number
- Z-1778-2017
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Apr 4, 2016
- Posted by the FDA
- Apr 11, 2017
- Recalling firm
- Merge Healthcare, Inc.
- Quantity
- 24 sites potentially have the affected versions
- Product code
- DQK
- FDA submissions
- K082421
- Distribution
- Nationwide Distribution including AZ, CA, CO, FL, GA, KS, LA, MI, MO, OH, OK, TN, TX, VA, WA, WI, and WV.
Product description
Merge Hemo software. The firm name on the labeling is Merge Healthcare, Hartland, WI. Merge Hemo monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure
Code information (models, lots, serial numbers)
Versions 9.10.0, 9.20.0, 9.20.1, 9.20.2, 9.30.3, and 9.40.0.
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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