FDAFDA · Food and drugs·Recall number Z-2154-2017
Philips DigitalDiagnost 3.1.x X-Ray System
Published June 21, 2017 · Recall initiated: May 11, 2017
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
During recent evaluations of the Philips DigitalDiagnost 3.1.x, we have identified a potential issue that may affect the performance of the equipment under certain conditions.
What to do
FDA Mandated · Letter
Recall details
- Manufacturer
- Philips Electronics North America Corporation
- Distributor
- USA(nationwide) Distribution to the states of : AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KY, LA, MA, ME, MI, MN, MO, NC, ND, NE, NH, NM, NY, OH, OK, OR, PA, TN, TX, UT, VA, WA and WI
- Lot
- DigitalDiagnost Upgrade Release 3.1.x to 3.1.3
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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