Ingenia 1.5T (Product Number 781396) - 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 one unit of the Ingenia 1.5T MRI system (Product Number 781396) with its HA FlexTrak II patient transportation trolley accessory (Accessory Number 989710008732) due to magnetic materials used in the trolley's wheels. The wheels containing magnetic material pose a risk of being attracted to the MRI system's magnetic field if positioned within that field. The affected unit has Ingenia Serial Number 41045 and Accessory Serial Number 100018.
The recalled equipment was distributed worldwide, including in Florida and New York in the United States, as well as in Denmark, Norway, and Sweden. The source document does not specify a remedy or recommended action for affected consumers.
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: 1 Lot/code info: UDI-DI 00884838009820 Ingenia Serial number 41045 Accessory Serial Number 100018
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.