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.
Reported: March 8, 2017 Initiated: April 8, 2016 #Z-1385-2017
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.
Reason for Recall
The software is not adding the correct tomo image.
Details
- Recalling Firm
- Merge Healthcare, Inc.
- Units Affected
- 28 sites potentially have the affected software
- Distribution
- US Nationwide Distribution in the states of AL CA, CO, FL, IL, MD, MN, MT, NV, NY, OR, PA SC, TN, and TX.
- Location
- Hartland, WI
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Merge Healthcare, Inc.. Units affected: 28 sites potentially have the affected software.
Why was this product recalled? ▼
The software is not adding the correct tomo image.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 8, 2017. Severity: Moderate. Recall number: Z-1385-2017.
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