Z-0974-2024 Class II Ongoing

Recalled by Philips North America — Cambridge, MA

Recall Details

Product Type
Devices
Report Date
February 14, 2024
Initiation Date
January 6, 2022
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2

Product Description

Ingenia Elition X (Product Number 781358) - HA FlexTrak II (Accessory Number 989710008732), patient transportation system

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 Pattern

Worldwide - US Nationwide distribution in the states of FL and NY. The countries of Denmark, Norway, and Sweden.

Code Information

UDI-DI 00884838088115 Ingenia Serial number / Accessory Serial Number 45294 100029 45294 100030