Recall Z-1799-2025 · LNH System, Nuclear Magnetic Resonance Imaging
Philips North America Llc
Product Name: Ingenia 1.5T CX; Model Number: 781262;
| Date | May 16, 2025 (initiated May 13, 2025) |
| Status | Open, Classified |
| Reason | Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application. |
| Root cause | Software design |
| Action | On May 12, 2025 URGENT MEDICAL DEVICE CORRECTION letters were sent to customers. Actions that should be taken by the customer / user in order to prevent risks for patients or users You may continue to use your system(s) in accordance with the intended use. A. To avoid the potential issue of an incorrect cross reference line in MobiView generated images, use the same voxel size and field of view across all station scans. B. Do not use cross reference line functionality in box mode, all slices mode, or 3D mode. Use the cross reference line functionality in single slice mode. Circulate this not |
| Quantity | 9 units (OUS Only) |
| Distribution | Worldwide distribution - US Nationwide and the countries of Andorra, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, C¿te D'Ivoire, Cyprus, Czech Republic, Denmark, Finland, France, French Guiana, Georgia, Germany, Greece, Guadeloupe, Hong Kong, Iceland, Indonesia, Iran, Ire |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K193215 | Achieva, Intera, Ingenia, Ingneia CX, Ingenia Elition, and Ingenia Ambition MR Systems Philips Medical Systems Nederland B.V., Apr 10, 2020 |