Recall Z-0973-2024 ยท LNH System, Nuclear Magnetic Resonance Imaging
Philips North America
Ingenia 1.5T (Product Number 781396) - 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 | 1 |
| 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
| K153324 | Ingenia 1.5T and Ingenia 1.5T S R5.2 Philips Medical Systems Nederlands B.V., Mar 22, 2016 |