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.
This recall has been terminated (originally issued March 2, 2017).
- Company
- Merge Healthcare, Inc.
- Recall Initiated
- April 8, 2016
- Posted
- March 2, 2017
- Terminated
- March 6, 2017
- Recall Number
- Z-1385-2017
- Quantity
- 28 sites potentially have the affected software
- Firm Location
- Hartland, WI
- Official Source
- View on FDA website ↗
Reason for Recall
The software is not adding the correct tomo image.
Distribution
US Nationwide Distribution in the states of AL CA, CO, FL, IL, MD, MN, MT, NV, NY, OR, PA SC, TN, and TX.
Lot / Code Info
Versions 11.0 and 11.0.1
Root Cause
Software design
Action Taken
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 recall@merge.com
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