Philips Achieva 1.5T MRI systems recalled for potential gradient coil fire risk
Philips is recalling Achieva 1.5T MRI systems due to potential gradient coil failure that could produce smoke and/or fire. Approximately 520 units have been distributed nationwide and internationally.
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 medical device recall involving a theoretical risk-of-harm hazard (potential fire and smoke from gradient coil failure) with no reported injuries or hospitalizations, meeting the rubric criterion for High severity.
Plain-English summary
Philips North America LLC is recalling Achieva 1.5T magnetic resonance imaging (MRI) systems due to a potential failure in the gradient coil component.
The potential component failure in the gradient coil could produce smoke and/or fire, posing a risk to patients and healthcare personnel in the vicinity of affected devices.
Approximately 520 units of the Achieva 1.5T have been distributed domestically throughout the United States and internationally to more than 50 countries, including Canada, Australia, Japan, Germany, France, and many others.
The recalled product
- Product
- Achieva 1.5T
- Manufacturer
- Philips North America Llc
- Hazard
- fire
- smoke
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. 781178
- 781196
- 781296
- & 781343
- UDI-DI: (01)00884838004108(21)8524
- (01)00884838004108(21)32039
- (01)00884838004108(21)32052
- (01)00884838004108(21)32083
- (01)00884838004108(21)32087
- (01)00884838004108(21)32097
- (01)00884838004108(21)32103
- (01)00884838004108(21)32118
- (01)00884838004108(21)32123
- (01)00884838004108(21)32150
- (01)00884838004108(21)32153
- (01)00884838004108(21)32154
- (01)00884838004108(21)32186
- (01)00884838004108(21)32223
- (01)00884838004108(21)32226
- (01)00884838004108(21)32228
Distribution
Distributed nationwide across the United States.
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