Recall Z-0330-2018 ยท JAA System, X-Ray, Fluoroscopic, Image-Intensified
Philips Electronics North America Corporation
CombiDiagnost R90 Image-Intensified fluoroscopic x-ray system CombiDiagnost R90 is a multi-functional general R/F system. It is suitable for all routine radiography and fluoroscopy exams, including specialist areas like angiography or pediatric work, excluding mammography
| Date | Oct 19, 2017 |
| Status | Terminated |
| Reason | The tube adapter-plate green/yellow protective earthing (PE) wire was removed. and spacers with different thickness were used to position pre-loc ring in respect to focal spot in specified distance. |
| Root cause | Nonconforming Material/Component |
| Action | Philips Medical System sent an Customer Notification letter dated October 19, 2017, and plans to have a Philips Field Service Engineer go to site to perform the field change order (FCO70900041) including: 1. Check for the presence of the PE cable and, if missing, install it. 2 .Perform a modified screw fixation. They expect to complete action by May 2018. For further questions, please call (978) 659-3000. |
| Quantity | 10 |
| Distribution | Worldwide Distribution - US Distribution and to the countries of : France, Germany, Luxembourg and New Zealand. |
| 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 |