Medical Device Recall: Philips MRI System Fire and Smoke Risk
Philips is recalling Achieva XR MRI systems (Models 781153, 781253) due to potential fire and smoke hazard from gradient coil component failures. Approximately 40 units 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 FDA Class II recall involves a fire and smoke hazard from component failure in diagnostic medical equipment. Although the hazard poses a potential risk of harm, no injuries, illnesses, or incidents have been reported. 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 Achieva XR magnetic resonance imaging (MRI) system, Model Numbers 781153 and 781253. A total of 40 units have been distributed worldwide, including throughout the United States and more than 80 countries.
The gradient coil component in the affected systems has the potential to fail and act as a heat source, which could produce smoke and/or fire. No illnesses or injuries have been reported to date.
Facilities operating the affected Achieva XR systems should contact Philips North America immediately for remediation instructions. Equipment should not be used until guidance from the manufacturer is received.
The recalled product
- Product
- Achieva XR; Model Numbers (REF): (1) 781153, (2) 781253;
- Manufacturer
- Philips North America
- Hazard
- fire
- smoke
- overheating
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) 781153
- (2) 781253
- UDI-DI: (1) None
- (2) None
- Serial Numbers: (1) 23003
- 23004
- 23005
- 23011
- 23014
- 23017
- 23020
- 23021
- 23028
- 23031
- 23035
- 23041
- 34039
- (2) 35004
- 35006
- 35007
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