FDA Enforcement
Class II
Terminated
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
Recall: Z-1004-2017
·
Reported January 18, 2017
Enforcement
- Recall Number
- Z-1004-2017
- Event ID
- 76021
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Philips Medical Systems (Cleveland) Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- January 18, 2017
- Initiation Date
- November 25, 2016
- Classification Date
- January 11, 2017
- Termination Date
- July 2, 2018
- Address
- 595 Miner Rd, Cleveland, OH, 44143-2131, United States
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
Failure to correctly document the installation of four M12 Bolts into the system rotor.
Code Info
Model Number 728306; System Serial Number 100619 Rorot-45535-673-94382 SN26
Distribution
The one system was distributed in Canada. There were no government or US distribution.
Quantity
1