FDAFDA · Food and drugs·Recall number Z-1385-2017
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.
Published March 8, 2017 · Recall initiated: April 8, 2016
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 is not adding the correct tomo image.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Merge Healthcare, Inc.
- Distributor
- US Nationwide Distribution in the states of AL CA, CO, FL, IL, MD, MN, MT, NV, NY, OR, PA SC, TN, and TX.
- Lot
- Versions 11.0 and 11.0.1
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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