FDAFDA · Food and drugs·Recall number Z-0801-2014
Computed Tomography X-Ray System (Brilliance CT Big Bore Oncology & Brilliance CT Big Bore Radiology) Distributed by Philips Healthcare System, Cleveland, OH. Produces cross-sectional body images by computer reconstruction of x-ray transmission data taken at different angles and planes.
Published January 29, 2014 · Recall initiated: December 4, 2013
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
Machine Name in TumorLOC Basic Mode is obscured. When TumorLOC is in Basic Mode and Set Vertical Laser equals Yes, the Machine Name label and field are covered by the controls above it. The Machine Name cannot be viewed or changed.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
- Distributor
- Worldwide Distribution-USA (nationwide) including the states of AK, MD, NH, NV, OH, and OR, and the countries of Australia, China, France, India, Indonesia, Italy, Korea, Mexico, Poland, Romania, Russia, Spain, Switzerland, Taiwan, Thailand & United Arab Emirates.
- Lot
- Model #: 728243; 7133, 7170, 7225, 7262, 7265, 7701, 7706, 7779, 7788, 7792, 7797, 7802, 7805, 7806, 7807, 7808, 7810, 7811, 7812, 7814, 7815, 7816, 7824, 7831, 7832, 7833, 7834 ,7835. Model #728244; 7621, 7636, 7809 & 7844.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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