Philips MRI System Gradient Coil Component May Overheat and Ignite Smoke or Fire
Philips has recalled 16 Intera 1.5T Achieva Nova MRI systems due to a gradient coil component that may overheat and produce smoke or fire, risking patient and operator injury.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This FDA Class II medical device recall involves a component with potential to cause fire, smoke, burns, and asphyxia that may lead to serious injury or death. Although no incidents have been reported, the potential for significant injury and property damage aligns with the Severe classification for Class II recalls with serious injury risk.
Plain-English summary
The Intera 1.5T Achieva Nova MRI system (Product Number 781172) manufactured by Philips North America is being recalled due to a potential component failure in the gradient coil assembly. The affected component can potentially act as a heat source, with the potential to produce smoke and/or fire.
Sixteen units (one in the United States and 15 internationally) have been affected. US distribution includes Arizona, California, Delaware, Massachusetts, Michigan, Nebraska, New York, and South Dakota. Internationally, units were distributed to Australia, Brazil, Ecuador, Germany, Iran, Italy, Japan, Lebanon, Libya, Mexico, Poland, Portugal, and Spain.
Should smoke or fire occur, patients and operators may face risks including smoke inhalation, thermal burns, and asphyxia. These conditions may result in serious injury or death. Property damage is also possible.
The recalled product
- Product
- Intera 1.5T Achieva Nova Product Number: 781172;
- Manufacturer
- Philips North America
- Hazard
- fire
- smoke-inhalation
- burn-injury
- asphyxia
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 (18)
- Product Number: 781172
- UDI-DI: no UDI
- Serial Numbers: 21218
- 21217
- 21216
- 21289
- 21349
- 12146
- 12063
- 12086
- 20069
- 21027
- 21198
- 12099
- 18641
- 21476
- 18623
- 12078
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- SevereMedline Spinal Block Kits Recalled for Data Integrity and Efficacy Issues
FDA (Devices) · 2026-06-03
- SevereAbiomed Automated Impella Controller recalled for motor control and pump failure risks
FDA (Devices) · 2026-06-03
- 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 anesthesia kits recalled for bupivacaine quality issues
FDA (Devices) · 2026-06-03