FDAFDA · Food and drugs·Recall number Z-1004-2017
Brilliance iCT Product Usage: 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 analysts and display equipment, patient and equipment supports, components, and accessories
Published January 18, 2017 · Recall initiated: November 25, 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
Failure to correctly document the installation of four M12 Bolts into the system rotor.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
- Distributor
- The one system was distributed in Canada. There were no government or US distribution.
- Lot
- Model Number 728306; System Serial Number 100619 Rorot-45535-673-94382 SN26
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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