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
Reported: January 18, 2017 Initiated: November 25, 2016 #Z-1004-2017
Product Description
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
Reason for Recall
Failure to correctly document the installation of four M12 Bolts into the system rotor.
Details
- Recalling Firm
- Philips Medical Systems (Cleveland) Inc
- Units Affected
- 1
- Distribution
- The one system was distributed in Canada. There were no government or US distribution.
- Location
- Cleveland, OH
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Philips Medical Systems (Cleveland) Inc. Units affected: 1.
Why was this product recalled? ▼
Failure to correctly document the installation of four M12 Bolts into the system rotor.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 18, 2017. Severity: Moderate. Recall number: Z-1004-2017.
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