Merge Cardio software. The firm name on the label is Merge… recallZ-1403-2017 · Merge Healthcare, Inc. · initiated Apr 4, 2016
Class II Terminated All recalls posted in March 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
When taking measurements from images on the Cardio workstation or from the US cart, numbers are not crossing to the report in the correct unit of measure.
FDA root cause category: Software design
What the company is doing
Merge sent an Urgent : Medical Device Recall letter dated March 28, 2016. If no email address was available, the letters were issued via certified mail. Nonresponders were issued a second letter dated July 11, 2016. For further questions, please call (877) 741-5369.
Recall details
- Recall number
- Z-1403-2017
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Apr 4, 2016
- Posted by the FDA
- Mar 3, 2017
- Recalling firm
- Merge Healthcare, Inc.
- Quantity
- 110 sites potentially have the affected versions
- Product code
- LLZ
- FDA submissions
- K051649
- Distribution
- Distribution was made to medical facilities nationwide. There was no foreign/military/government distribution.
Product description
Merge Cardio software. The firm name on the label is Merge Healthcare, Hartland, WI.
Code information (models, lots, serial numbers)
Versions 9.0, 9.0.1, 9.0.2, 9.0.3, 9.0.4, 9.0.5, 9.0.6, 9.0.7, 9.0.8, 9.0.9, and 10.0.
Other devices under the same FDA submission
4 devices cleared under K051649 — 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 Cardio V11.1Merge Healthcare Solutions Inc. · System, Image Processing, Radiological2 recalls14 reports
- Merge Cardio 10.3Merge Healthcare Solutions Inc. · System, Image Processing, Radiological2 recalls13 reports
- Merge Cardio 11.0Merge Healthcare Solutions Inc. · System, Image Processing, Radiological2 recalls8 reports
- Merge Cardio 12.1Merge Healthcare Solutions Inc. · System, Image Processing, Radiological1 recall1 death8 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.
How recalls are matched to devices · Editorial policy · Report an error on this page