FDAFDA · Food and drugs·Recall number Z-1180-2017
Merge RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI.
Published February 15, 2017 · Recall initiated: November 17, 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 values provided from the Pixel Value tool do not appear to be correct, which may result in potential patient injury or delay in diagnosis or treatment.
What to do
Voluntary: Firm initiated · Other
Recall details
- Manufacturer
- Merge Healthcare, Inc.
- Distributor
- US Distribution was made to medical facilities in AL, IN, MI, PA and WI.
- Lot
- Version V8.30.7.8
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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