The Recall Desk
HighFDA (Devices)·Z-0975-2024·Announced 2024-02-14

Patient transportation system wheels may be attracted to MRI magnetic fields

Ingenia Ambition X patient transportation system trolleys contain magnetic wheels that may be attracted to MRI magnetic fields, potentially causing trolley malfunction during patient procedures.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a risk-of-harm product (patient transportation system) where a potential malfunction due to magnetic attraction could affect patient safety. No injuries or illnesses have been reported. The hazard is theoretical in nature and the recall is classified as FDA Class II, resulting in a score of 3 per the rubric criteria.

Plain-English summary

The Ingenia Ambition X (Product Number 781356) patient transportation system with HA FlexTrak II accessory (Accessory Number 989710008732) is being recalled due to magnetic materials used in the trolley wheels. The wheels may be attracted to MRI (magnetic resonance imaging) magnetic fields if the trolley is positioned within the magnetic field of an MRI system.

This magnetic attraction could cause the trolley to move unexpectedly or malfunction, potentially affecting patient safety during transport or procedures involving MRI systems. The recall affects 10 units distributed in Florida and New York in the United States, as well as units in Denmark, Norway, and Sweden.

Facilities with affected units should identify whether they have impacted trolleys by consulting the provided serial numbers. Affected units should not be used in proximity to active MRI systems until the issue is resolved.

The recalled product

Product
Ingenia Ambition X (Product Number 781356) - HA FlexTrak II (Accessory Number 989710008732), patient transportation system
Manufacturer
Philips North America
Hazard
  • magnetic-attraction
  • equipment-malfunction

Distribution

Distributed nationwide across the United States.