Recall Z-2395-2023 ยท LNH System, Nuclear Magnetic Resonance Imaging
Philips North America
Ingenia Elition X Magnetic Resonance (MR) system, Product Numbers 781358, 782107, and 782118 (SmartPath to Ingenia Elition X)
| Date | Aug 11, 2023 (initiated Jun 12, 2023) |
| Status | Open, Classified |
| Reason | The system operator is able to bypass the SmokeDetector Interlock system locking mechanism after a smoke detection by power cycling the system. |
| Root cause | Under Investigation by firm |
| Action | An URGENT Medical Device Correction Notice dated 6/5/23 was sent to customers. Actions that should be taken by the customer / user in order to prevent risks for patients or users: 4.1. Philips has installed a SmokeDetector Interlock feature on all the systems listed in Appendix A. Post this notice near the affected MR system(s) for ease of reference. Circulate this notice to all users of this device so that they are aware of the product issue and associated hazard/harm until this issue has been resolved. Please complete and return the attached updated customer response form to Philips pro |
| Quantity | 640 total |
| Distribution | US Nationwide. Global Distribution. |
| 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 |