FDAFDA · Food and drugs·Recall number Z-1706-2017
Mobile Diagnostic X-Ray System with Digital Panel
Published April 12, 2017 · Recall initiated: November 28, 2012
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
When the operator moves an image to another view then the electronic marker might be placed at the wrong anatomical position in the resulting image.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Philips Healthcare Inc.
- Distributor
- Nationwide (AR, AZ, CA, DE, FL, GA, IA, IL, IN, KS, MD, MI, MN, NC, NM, NY, OH, OR, PA, SC, TX, VT, WI)
- Lot
- *** All units ***
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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