FDAFDA · Food and drugs·Recall number Z-0611-2017
iConnect Access software. The firm name on the label is Merge Healthcare, Hartland, WI.
Published November 23, 2016 · Recall initiated: May 25, 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
Software displayed incorrect prior reports in the viewport area, only when more than one prior study (2 or more) was viewed.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- Merge Healthcare, Inc.
- Distributor
- Distribution was made to medical facilities nationwide. Foreign distribution was also made.
- Lot
- Versions 3.0.1, 3.1, and 3.2
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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