Recall Z-2357-2021
Philips Medical Systems Gmbh, DMC · initiated July 22, 2020
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
CombiDiagnost R90 Software Version R1.0 and R1.1
Codes / lots: Model 706100
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.
FDA-determined 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.
Details
- Recall number
- Z-2357-2021
- Initiated
- July 22, 2020
- Product code
- JAA – System, X-Ray, Fluoroscopic, Image-Intensified
- Quantity
- 322 systems; 66 in US
- Distribution
- US Nationwide Distribution
- Recalling firm
- Philips Medical Systems Gmbh, DMC, Hamburg