Ingenia Ambition X (Product Number 781356) - HA FlexTrak II (Accessory Number 989710008732), patient transportation syst
FDA device recall Z-0975-2024 · 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
- 10
- 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 |
|---|---|---|
| Achieva, Intera, Ingenia, Ingneia CX, Ingenia Elition, and Ingenia Ambition MR Systems (K193215) | Philips Medical Systems Nederland B.V. | 2020-04-10 |
| Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems (K183063) | Philips Medical Systems Nederland B.V. | 2019-02-14 |
| Ingenia Ambition S and Ingenia Ambition X (K181479) | Philips Medical Systems Nederland B.V. | 2018-08-03 |