MRI systems at risk of unintended magnet shutdown during power loss
Philips Ingenia Ambition X and S MRI systems may experience uncontrolled shutdown of the sealed magnet if cryo-cooling is lost due to power outages. This could disrupt patient scans and operations.
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: FDA Class II recall without reported hospitalizations or injuries. The magnet shutdown hazard poses operational risk to equipment and patient scanning, but no reported incidents or harm are documented. This matches the rubric criterion for Score 3: risk-of-harm product where injury has not yet been reported.
Plain-English summary
Philips North America is recalling certain Ingenia Ambition X (Product Number 781356) and Ingenia Ambition S (Product Number 781359) MRI systems. These are magnetic resonance imaging systems used in clinical settings.
The sealed magnet in these systems may experience uncontrolled shutdown, known as Loss-of-Field (LoF), if the system loses cryo-cooling. This can occur during a power outage or similar loss of cooling supply.
The recall affects 56 units in the United States and 169 units internationally across the specified serial number ranges. Facilities operating these systems should verify their serial numbers and contact Philips for further instructions.
No injuries or illnesses have been reported in association with this issue. Operators should ensure backup power systems are in place to maintain cryo-cooling and prevent this condition.
The recalled product
- Product
- (1) Ingenia Ambition X (Product Number 781356); (2) Ingenia Ambition S (Product Number 781359)
- Manufacturer
- Philips North America
- Category
- Medical Device — MRI Systems
Distribution
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