DR Systems Unity PACS software, now known as Merge Unity… recallZ-1385-2017 · Merge Healthcare, Inc. · initiated Apr 8, 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
The software is not adding the correct tomo image.
FDA root cause category: Software design
What the company is doing
Merge sent an Urgent Medical Device Recall dated July 11, 2016 to affected customers. The letter identified the affected product, problem and actions to be taken. For questions send an email to [email protected]
Recall details
- Recall number
- Z-1385-2017
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Apr 8, 2016
- Posted by the FDA
- Mar 2, 2017
- Recalling firm
- Merge Healthcare, Inc.
- Quantity
- 28 sites potentially have the affected software
- Product code
- LLZ
- FDA submissions
- K041935
- Distribution
- US Nationwide Distribution in the states of AL CA, CO, FL, IL, MD, MN, MT, NV, NY, OR, PA SC, TN, and TX.
Product description
DR Systems Unity PACS software, now known as Merge Unity PACS. Product Usage: Merge Unity PACS is a medical image and information management system that allows viewing, selection, processing, printing, telecommunications, and media interchange of medical images from a variety of diagnostic imaging systems.
Code information (models, lots, serial numbers)
Versions 11.0 and 11.0.1
Other devices under the same FDA submission
4 devices cleared under K041935 — 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 Unity PACS 11.1.2Merge Healthcare Solutions Inc. · System, Image Processing, Radiological18 reports
- Merge Unity PACS 12.0Merge Healthcare Solutions Inc. · System, Image Processing, Radiological11 reports
- Merge Unity Pacs 11.0Merge Healthcare Solutions Inc. · System, Image Processing, Radiological6 reports
- Merge Unity PACS 11.2Merge Healthcare Solutions Inc. · System, Image Processing, Radiological4 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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