Recall Z-0975-2024 ยท LNH System, Nuclear Magnetic Resonance Imaging
Philips North America
Ingenia Ambition X (Product Number 781356) - HA FlexTrak II (Accessory Number 989710008732), patient transportation system
| Date | Feb 2, 2024 (initiated Jan 6, 2022) |
| Status | Open, Classified |
| Reason | Magnetic materials were used for the wheels of trolley. Wheels with magnetic material might be attracted to MRI systems if the wheels are in the magnetic field. |
| Root cause | Device Design |
| Action | Beginning in January 2022, Philips Field Service Engineers (FSE) visited impacted customer sites to replace the magnetic castor wheels of the HA Flextrack Trolley II with non-magnetic castor wheels. All reachable systems were addressed as of August 10, 2023. |
| Quantity | 10 |
| Distribution | Worldwide - US Nationwide distribution in the states of FL and NY. The countries of Denmark, Norway, and Sweden. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K181479 | Ingenia Ambition S and Ingenia Ambition X Philips Medical Systems Nederland B.V., Aug 3, 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 |