FDAFDA · Food and drugs·Recall number Z-0939-2017
DR Systems Unity PACS software, now known as Merge Unity PACS software.
Published January 11, 2017 · Recall initiated: October 15, 2015
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The software fails to associate to the correct MG image if there are two images for the same view.
What to do
Voluntary: Firm initiated · Other
Recall details
- Manufacturer
- Merge Healthcare, Inc.
- Distributor
- Distribution was made to medical facilities located in MT, CA, PA, and TX.
- Lot
- Version 11.0
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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