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Recall Observatory FDA recall evidence

Device product

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

Z-0974-2024

January 06, 2022

Class II

Product summary

Firm
Philips North America
Event
Event 93737
Status
Ongoing
Classification
Class II
Quantity
2
Official record key
device-enforcement:Z-0974-2024

Official wording

Reason: 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.

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

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.