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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
- Category
- Medical Device
- Affected units
- 10
Distribution
Part of a larger recall action
This product is one of 3 recalled by Philips North America under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
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