FDAFDA · Food and drugs·Recall number Z-1176-2017
Merge PACS software. The firm name on the label is Merge Healthcare, Hartland, WI.
Published February 15, 2017 · Recall initiated: April 4, 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
Potential exists for an incorrect patient image being displayed which could result in the delay in diagnosis or treatment.
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 in AZ, CA, CO, FL, HI, IL, MA, MD, MI, MO, NY, OH, PA, SC, TN, UT, and WI. There was no foreign/government/military distribution.
- Lot
- Version 7.0.1
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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