Recall Z-1588-2023 ยท JAA System, X-Ray, Fluoroscopic, Image-Intensified
Philips North America
CombiDiagnost R90 R.1.0
| Date | May 15, 2023 (initiated Mar 3, 2023) |
| Status | Open, Classified |
| Reason | Philips has identified a compliance issue where ProxiDiagnost N90 R.1.0, CombiDiagnost R90 R.1.0 and CombiDiagnost R90 R1.1 systems are missing a certification label required by the Food and Drug Administration (FDA). |
| Root cause | Radiation Control for Health and Safety Act |
| Action | Philips sent an Electronic Product Radiation Correction letter dated March 3, 2023, to affected customers. The letter stated a Philips representative will contact affected customers to schedule a time for a Field Service Engineer (FSE) to visit your site to inspect your system and apply the label if necessary. Philips will, without charge, remedy the defect or bring the product into compliance with each applicable Federal standard in accordance with a plan approved by the Secretary of Health and Human Services. Customers were asked to complete and return the attached acknowledgement form t |
| Quantity | 25 systems in total |
| Distribution | US Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K163210 | Philips CombiDiagnost R90 Philips Medical Systems Dmc GmbH, Jan 31, 2017 |