FDAFDA · Food and drugs·Recall number Z-0832-2014
Brilliance iCT & Brilliance iCT SP Computed Tomography X-Ray Systems, Philips Healthcare, Cleveland, OH The Brilliance iCT and iCT SP are whole body Computed Tomography X-Ray Systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient and equipment supports, components and accessories.
Published February 5, 2014 · Recall initiated: December 9, 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
Patient images exhibited ring artifacts.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
- Distributor
- Worldwide Distribution: US (nationwide) including states of: FL, IN, NY, OR and PA; and internationally to: Australia and Israel.
- Lot
- Brilliance iCT: 728306, Serial #'s: 100018, 100040, 100411, 100503, 100506 Brilliance iCT SP: 728311, Serial #'s: 200047, 200121
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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