Merge Cardio software. The firm name on the label is Merge… recallZ-2709-2016 · Merge Healthcare, Inc. · initiated Feb 9, 2016
Class II Terminated All recalls posted in September 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
A report can be confirmed with the incorrect patient demographics resulting in it being saved under the incorrect patient record in the Electronic Medical Record (EMR).
FDA root cause category: Software design
What the company is doing
MERGE sent an Urgent Medical Device Recall letter dated February 9, 2016, to all affected customers via email or via certified mail if they did not have an e-mail address for the customer. The notification instructs the customer to pass the information onto all other users, as well as any downstream customers if it was further distributed. In addition, the customer is requested to call Customer Service or send them an email to schedule the upgrade. If the customer chooses not to upgrade, they are requested to complete the attached form or go online and complete it. For further questions, please call (800) 724-5970 ext. 8027.
Recall details
- Recall number
- Z-2709-2016
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Feb 9, 2016
- Posted by the FDA
- Sep 1, 2016
- Recalling firm
- Merge Healthcare, Inc.
- Quantity
- 116 customers potentially have the affected versions
- Product code
- LLZ
- FDA submissions
- K051649
- Distribution
- Nationwide Distribution
Product description
Merge Cardio software. The firm name on the label is Merge Healthcare, Hartland, WI. Image processing system.
Code information (models, lots, serial numbers)
Versions 10.1 and 10.1.1
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.
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