Device product
CombiDiagnost R90 Software Version R1.0 and R1.1
Z-2357-2021
Product summary
- Event
- Event 88393
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 322 systems; 66 in US
- Official record key
device-enforcement:Z-2357-2021
Official wording
Reason: Philips has become aware of a software issue, where the kV and mA values are not locked immediately but change when the collimator shutter position is changed directly after the Lock-In command. This software issue leads to an over or under exposed image.
Code information: Model 706100
Distribution pattern: US Nationwide Distribution
Derived failure modes
-
Device software or design
software issue