Recall Z-2357-2021 ยท JAA System, X-Ray, Fluoroscopic, Image-Intensified
Philips Medical Systems Gmbh, DMC
CombiDiagnost R90 Software Version R1.0 and R1.1
| Date | Jul 22, 2020 |
| Status | Open, Classified |
| 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. |
| Root cause | Radiation Control for Health and Safety Act |
| Action | 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. |
| Quantity | 322 systems; 66 in US |
| Distribution | US Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K203087 | CombiDiagnost R90 Philips Medical Systems Dmc GmbH, Dec 3, 2020 |