Ingenia Elition X (Product Number 781358) - HA FlexTrak II (Accessory Number 989710008732), patient transportation syste
FDA device recall Z-0974-2024 · posted 2024-02-02 · Open, Classified
Recall details
- Recalling firm
- Philips North America
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Device Design
- Status
- Open, Classified
- Product code
- LNH
- Quantity affected
- 2
- Distribution
- Worldwide - US Nationwide distribution in the states of FL and NY. The countries of Denmark, Norway, and Sweden.
- Date initiated
- 2022-01-06
- Date posted
- 2024-02-02
- Location
- Cambridge, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Ingenia Elition S and Ingenia Elition X (K173451) | Philips Medical Systems Nederland B.V. | 2018-03-20 |
| Ingenia Elition S and Ingenia Elition X R5.4 (K173356) | Philips Medical Systems Nederland B.V. | 2018-03-06 |