Ingenia Elition X (Product Number 781358) - HA FlexTrak II (Accessory Number 989710008732), patient transportation system
Check against the official notice below — it lists the full affected range.
Philips North America is recalling the Ingenia Elition X patient transportation system (Product Number 781358) with HA FlexTrak II accessory (Accessory Number 989710008732) because the trolley wheels contain magnetic materials that could be attracted to MRI systems when in the magnetic field. Two units were distributed worldwide, including in Florida and New York in the United States, and in Denmark, Norway, and Sweden.
The affected devices have UDI-DI 00884838088115 with Ingenia serial numbers 45294 100029 and 45294 100030. The recall notice does not specify a remedy or action for consumers to take.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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: 2 Lot/code info: UDI-DI 00884838088115 Ingenia Serial number / Accessory Serial Number 45294 100029 45294 100030
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.