Recall Z-0241-2022 ยท JAA System, X-Ray, Fluoroscopic, Image-Intensified
Philips Healthcare
CombiDiagnost R90 is multi-functional general R/F systems.
| Date | Sep 22, 2021 |
| Status | Open, Classified |
| Reason | The Aleva monitor requires certain labels to be applied, some of which are required by FDA Electronic Product Radiation Control performance standards. This includes the Radiation Warning Label [21CFR 1020.30 (j)] and the X-ray control certification statement [21 CFR 1010.2]. Philips has determined that some systems at customer locations did not have these labels applied. |
| Root cause | Radiation Control for Health and Safety Act |
| Action | Philips sent an Electronic Product Radiation Correction letter to inform customers. The letter identified the affected product, problem and actions to be taken. Customers were informed Philips Field Service Engineer will visit their site to check for the required labels and if they are missing, will resolve the issue by applying the required labels. Customers were instructed to complete and return the attached acknowledgment form to Philips DXR via email to DIFCO@philips.com. For questions contact Customer Care Solutions Center 1-800-722-9377. |
| Quantity | 281 in total |
| 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 |