FDAFDA · Food and drugs·Recall number Z-0376-2017
Philips Healthcare System X-ray Tomography Computed :
Published November 30, 2016 · Recall initiated: March 15, 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
It was discovered the patient support tabletop may fail to move in the horizontal direction when it is commanded to do so during CT scans due to a potential mechanical linkage failure.
What to do
FDA Mandated · Letter
Recall details
- Manufacturer
- Philips Electronics North America Corporation
- Distributor
- USA(nationwide) Distribution to the states of : AZ, NY, GA, UT, TN, TX, AR, NV, Il, FL, MS, LA, MD, MO, MA, OK, KY, WY, SC, ND, NE, DE, MI, WA, CT, RI, KS, OR, IN, PA, CA, NJ, NC, MN, AL and IA.
- Lot
- Ingenuity CT, Ingenuity Core, Ingenuity Core 128.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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