Skip to content
Recall Observatory FDA recall evidence

Device product

Ingenia Ambition X (Product Number 781356) - HA FlexTrak II (Accessory Number 989710008732), patient transportation system

Z-0975-2024

January 06, 2022

Class II

Product summary

Firm
Philips North America
Event
Event 93737
Status
Ongoing
Classification
Class II
Quantity
10
Official record key
device-enforcement:Z-0975-2024

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 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

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.