Patient Transportation System Recalled for Magnetic Wheel MRI Interference Risk
Philips is recalling Ingenia Elition X patient transportation systems due to magnetic wheels that may be attracted to MRI systems, posing a patient safety risk if used in MRI environments.
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 an FDA Class II recall for a medical device used in patient care. While no injuries or illnesses are reported, the hazard represents a real risk of device malfunction in MRI environments that could affect patient safety. Per the rubric, risk-of-harm products where injury has not yet been reported score as High (3).
Plain-English summary
Philips North America is recalling the Ingenia Elition X patient transportation system (Product Number 781358) with HA FlexTrak II accessory (Accessory Number 989710008732). The trolley wheels contain magnetic materials.
The magnetic materials in the wheels may be attracted to MRI systems if the trolley is positioned in the magnetic field. This could cause unintended device movement or malfunction during patient care in MRI environments, posing a risk to patient safety.
This recall affects 2 units with worldwide distribution, including Florida and New York in the United States, as well as Denmark, Norway, and Sweden. The affected serial numbers are 45294 100029 and 45294 100030.
Facilities and patients should take precautions to keep this equipment away from MRI magnetic fields. For specific guidance on this recall, contact Philips North America.
The recalled product
- Product
- Ingenia Elition X (Product Number 781358) - HA FlexTrak II (Accessory Number 989710008732), patient transportation system
- Manufacturer
- Philips North America
- Affected units
- 2
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.
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