Philips MR 7700 Imaging Systems Recalled for Potential Fire Hazard
Philips is recalling MR 7700 imaging systems due to potential component failures in the gradient coil that may produce smoke and fire. The recall affects 82 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 addresses potential fire and smoke hazards from gradient coil component failures in medical imaging equipment. No incidents have been reported and the hazard remains theoretical, meeting the criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Philips North America is recalling certain MR 7700 magnetic resonance imaging systems. The affected devices include model numbers 782120 (UDI-DI: 00884838104112) and 782153 (UDI-DI: 00884838112858), with a total of 82 units involved.
Component failures in the gradient coil of these imaging systems may act as a heat source with potential to produce smoke and/or fire. This potential safety hazard prompted the recall of the affected devices.
The recalled systems were distributed worldwide, including throughout the United States and to numerous countries globally. Specific serial numbers for each model variant are identified in the official FDA recall notice (FDA Recall Z-2214-2025).
The recalled product
- Product
- MR 7700 Model Numbers (REF): (1) 782120, (2) 782153;
- Manufacturer
- Philips North America
- 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)
- Model Numbers (REF): (1) 782120
- (2) 782153
- UDI-DI: (1) 00884838104112
- (2) 00884838112858
- Serial Numbers: (1) 65000
- 65001
- 65002
- 65003
- 65004
- 65005
- 65006
- 65007
- 65008
- 65009
- 65011
- 65012
- 65013
- 65014
- 65015
- 65016
Distribution
Distributed nationwide across the United States.
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