Philips Ingenia Ambition S MRI Systems Gradient Coil Fire Risk
Philips is recalling 611 Ingenia Ambition S MRI systems due to potential gradient coil component failures that could generate heat, smoke, or fire. The affected units were distributed worldwide.
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 an FDA Class II recall involving MRI systems with potential for fire and smoke from component failure. The source text does not report any injuries or illnesses, placing this recall in the 'risk-of-harm products where injury has not yet been reported' category, warranting a High severity score.
Plain-English summary
Philips North America is recalling 611 Ingenia Ambition S MRI (magnetic resonance imaging) systems across four model numbers: 781359, 782108, 782133, and 782139. The systems were distributed worldwide, including throughout the United States and numerous countries globally.
The gradient coil component in the affected systems may experience component failures that act as a heat source with potential to produce smoke and/or fire. This hazard poses a risk to patients and healthcare facility staff.
Facilities using these systems should identify affected equipment by checking model and serial numbers against the official FDA recall notice at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=Z-2208-2025. The recall specifies affected serial numbers for each model.
Affected healthcare facilities should contact Philips North America immediately for instructions on repair, replacement, or remediation of the gradient coil component in their systems.
The recalled product
- Product
- Ingenia Ambition S Model Numbers (REF): (1) 781359, (2) 782108, (3) 782133 (China ONLY), (4) 782139;
- Manufacturer
- Philips North America
- Category
- Medical Device — MRI Systems
- Hazard
- fire
- smoke
- heat-damage
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Model Numbers (REF): (1) 781359
- (2) 782108
- (3) 782133 (China ONLY)
- (4) 782139
- UDI-DI: (1) 00884838090057
- (2) 00884838098343
- (3) None
- (4) 00884838108639
- Serial Numbers: (1) 48000
- 48001
- 48003
- 48004
- 48005
- 48009
- 48010
- 48011
- 48012
- 48013
- 48014
- 48015
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- HighGE APEXPRO and CARESCAPE Telemetry Systems Risk Loss of Patient Monitoring
FDA (Devices) · 2026-06-03
- CriticalMedline spinal anesthetic kits recalled for quality and efficacy concerns
FDA (Devices) · 2026-06-03
- SevereMedline Spinal Trays Recalled Due to Quality and Efficacy Concerns
FDA (Devices) · 2026-06-03
- SevereMedline spinal anesthesia kits recalled for bupivacaine quality issues
FDA (Devices) · 2026-06-03
- HighMedline Medical Convenience Kit Recalled: Wrong Syringe Type Inside
FDA (Devices) · 2026-06-03