FDAFDA · Food and drugs·Recall number Z-1656-2015
Brilliance iCT. 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.
Published June 3, 2015 · Recall initiated: March 16, 2015
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 firm was informed that while raising the patient couch on the system to perform an exam, the couch unexpectedly descended to the lowest point without being commanded to do so.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
- Distributor
- Distributed in China.
- Lot
- System Code #, 728306, Serial #, 100067, 100137, 100179, 100226, 100233, 100293, 100294 & 100342.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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