Ingenia Elition X (Product Number 781358) - 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-0974-2024
- Quantity
- 2
- 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 00884838088115 Ingenia Serial number / Accessory Serial Number 45294 100029 45294 100030
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.