Philips MRI systems recalled for potential gradient coil fire hazard
Philips is recalling 102 Intera 1.5T MRI systems worldwide due to a potential gradient coil failure that could produce smoke and fire. The affected devices are identified by product numbers 781195 and 781295.
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 a potential fire and smoke hazard from gradient coil failure. While the risk of serious harm is significant, no injuries or deaths have been reported in the source material, and the hazard is characterized as potential rather than confirmed. This meets the High severity level for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Philips North America LLC is recalling 102 units of the Intera 1.5T MRI (magnetic resonance imaging) system. The recall is for a potential failure in the gradient coil component that could produce smoke and/or fire.
The affected systems were distributed domestically throughout the United States and internationally to numerous countries worldwide. The devices are identified by product numbers 781195 and 781295. Specific serial numbers of affected units are detailed in the FDA recall notice (Z-0393-2024).
The recalled product
- Product
- Intera 1.5T
- Manufacturer
- Philips North America Llc
- Hazard
- fire
- smoke
- component-failure
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)
- Product No. 781195 & 781295
- UDI-DI: N/A
- Serial No. 18510
- 18516
- 18529
- 18550
- 18564
- 18567
- 18578
- 18583
- 18592
- 18657
- 18660
- 18667
- 18678
- 18701
- 18709
- 18711
- 18714
- 18725
Distribution
Distributed nationwide across the United States.
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