Ingenia Ambition X (Product Number 781356) - HA FlexTrak II (Accessory Number 989710008732), patient transportation system
This recall is currently active, issued February 2, 2024. It was issued by Philips North America.
- Company
- Philips North America
- Recall Initiated
- January 6, 2022
- Posted
- February 2, 2024
- Recall Number
- Z-0975-2024
- Quantity
- 10
- Firm Location
- Cambridge, MA
- Official Source
- View on FDA website ↗
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.
Distribution
Worldwide - US Nationwide distribution in the states of FL and NY. The countries of Denmark, Norway, and Sweden.
Lot / Code Info
UDI-DI 00884838090040 Ingenia Serial number / Accessory Serial Number 47004 100020 47019 100024 47190 100022 47200 100025 47210 100019 47227 100063 47231 100056 47271 100032 47281 100028 47281 100031
Root Cause
Device Design
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.