CombiDiagnost R90 Software Version R1.0 and R1.1
This recall is currently active, issued July 22, 2020. It was issued by Philips Medical Systems Gmbh, Dmc Development And Manufacturing Ctr. Rontgenstr. 24-26 Hamburg Germany.
- Recall Initiated
- July 22, 2020
- Recall Number
- Z-2357-2021
- Quantity
- 322 systems; 66 in US
- Official Source
- View on FDA website ↗
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
US Nationwide Distribution
Lot / Code Info
Model 706100
Root Cause
Radiation Control for Health and Safety Act
Action Taken
Philips sent customers an Electronic Product Radiation Correction letter dated July 14, 2021. The letter identified the affected product, problem and actions to be taken. Philips plans to correct the defect at no cost to customers by implementing a field correction involving the installation of a software update. For questions contact the Customer Care Solutions Center 1-800-722-9377 and reference FCO70900051.