Z-2357-2021 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- September 8, 2021
- Initiation Date
- July 22, 2020
- Termination Date
- N/A
- Voluntary/Mandated
- FDA Mandated
- Product Quantity
- 322 systems; 66 in US
Product Description
CombiDiagnost R90 Software Version R1.0 and R1.1
Reason for Recall
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.
Distribution Pattern
US Nationwide Distribution
Code Information
Model 706100