FDAFDA · Food and drugs·Recall number Z-0791-2014
Brilliance iCT, Brilliance 64 and Brilliance Big Bore The Brilliance iCT, Brilliance 64 and Brilliance Big Bore are 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. These devices may include signal analysis and display equipment, patient, and equipment supports, components and accessories.
Published February 5, 2014 · Recall initiated: March 7, 2011
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
The DoseRight feature suggest a mAs based on the measured patient size, a reference size and a reference mAs. When scanning large children, the suggested mAs may be higher than clinicians would expect.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
- Distributor
- Worldwide Distribution - US Distribution including the states of DC, IL, IN, MI, MO, NY, OH, OR, PA, TX and VT., and the countries of Australia, Belgium, China, Germany, India, Israel, Italy and The Netherlands.
- Lot
- Brilliance iCT: Model Number 728311 and 728306, Serial Number: 100103, 100019, 100023, 100170, 200047, 200013 200005 and 100087. Brilliance 64: Model Number 728231 and 728326, Seial Number: 4003, 9745, 9875, 90135, 90169, 95414, 300003, 300004, 300005 and 300010. Brilliance CT Big Bore, Model Number: 728243, Serial Number: 7006, 7060, 7154, 7298 and 7349.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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