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FDA (Device enforcement)Recalled 2022-01-06class ii

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

Is my product affected?

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

  • UPC 00884838090040

Check against the official notice below — it lists the full affected range.

What happened

Philips North America is recalling the Ingenia Ambition X patient transportation system (Product Number 781356) with HA FlexTrak II accessory (Accessory Number 989710008732) because the trolley wheels contain magnetic materials that could be attracted to MRI systems when positioned in the magnetic field. Ten units with the specified serial numbers were distributed worldwide, including to Florida and New York in the United States, as well as to Denmark, Norway, and Sweden.

The recall record does not specify a remedy or instructions for what affected consumers should do.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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.

Details from the source

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. Quantity: 10 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

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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