Recall Z-0460-2023 ยท LNH System, Nuclear Magnetic Resonance Imaging
Philips North America Llc
Philips Ingenia Elition X MR System, Model Numbers 781358, 782107, 782119, 782136
| Date | Dec 8, 2022 (initiated Nov 22, 2022) |
| Status | Open, Classified |
| Reason | Gradient Coil may act as a heat source with a potential to produce smoke and/or fire. |
| Root cause | Under Investigation by firm |
| Action | An URGENT Medical Device Correction Notice dated 11/22/22 was sent to customers. Actions that should be taken by the customer / user in order to prevent risks for patients or users 1. Systems that do not yet have the SmokeDetector Interlock feature installed are identified in Appendix A. If your system is listed in Appendix A immediately discontinue use of your impacted MR system(s) until Philips has installed the SmokeDetector Interlock. " Post a Do not use notice on or near the impacted MR system(s) " Post this notice near the affected MR system(s) for ease of reference. " Circulate this |
| Quantity | 566 total |
| Distribution | US Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K173356 | Ingenia Elition S and Ingenia Elition X R5.4 Philips Medical Systems Nederland B.V., Mar 6, 2018 |
| K173451 | Ingenia Elition S and Ingenia Elition X Philips Medical Systems Nederland B.V., Mar 20, 2018 |
| K183063 | Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems Philips Medical Systems Nederland B.V., Feb 14, 2019 |
| K193215 | Achieva, Intera, Ingenia, Ingneia CX, Ingenia Elition, and Ingenia Ambition MR Systems Philips Medical Systems Nederland B.V., Apr 10, 2020 |
| K213516 | Ingenia 3.0T, Ingenia 3.0T CX, Ingenia Elition and MR 7700 with Distributed Multi Nudclei Philips Medical Systems Nederland B.V., Mar 3, 2022 |