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
This recall has been terminated (originally issued November 25, 2016).
- Recall Initiated
- November 25, 2016
- Terminated
- July 2, 2018
- Recall Number
- Z-1004-2017
- Quantity
- 1
- Firm Location
- Cleveland, OH
- Official Source
- View on FDA website ↗
Reason for Recall
Failure to correctly document the installation of four M12 Bolts into the system rotor.
Distribution
The one system was distributed in Canada. There were no government or US distribution.
Lot / Code Info
Model Number 728306; System Serial Number 100619 Rorot-45535-673-94382 SN26
Root Cause
Employee error
Action Taken
Philips sent a Customer Information Letter to their customer. The letter identified the affected product, problem description and actions to be taken by customers. For further information or support concerning this issue, contact your local Philips representative or local Philips Healthcare office. For SUPPORT North America and Canada, contact the Customer Care Solutions Center (1-800-722-9377).