Brilliance 64 with 4.1.7 XX026 software version model number 728231 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 analysis and display equipment, patient and equipment supports, components, and accessories
This recall has been terminated (originally issued February 21, 2018).
- Recall Initiated
- February 21, 2018
- Terminated
- April 10, 2020
- Recall Number
- Z-1396-2018
- Quantity
- 291
- Firm Location
- Cleveland, OH
- Official Source
- View on FDA website ↗
Reason for Recall
Surview scan with tube current lower than 30 mA is unable to be initialized.
Distribution
Worldwide Distribution - US Nationwide in the states of GA, VA, MI, AZ, and the countries of Canada, Switzerland
Lot / Code Info
Serial numbers: . 9134 9667 9738 9788 9923 10773 95263 95669
Root Cause
Under Investigation by firm
Action Taken
On February 21, 2018 Philips Medical Systems sent a Customer Information Letter regarding the Philips Brilliance 64 Software Model 4.1.7. Customers were informed of how to identify affected products and instructed to use the Instructions For Use recommended 30mA for surview scans. Customers with questions or concerns should contact their local Philips representative or local Philips Healthcare office Customer Care Solutions Center at 1-800- 722-9377.