Philips Achieva 3.0T gradient coils may act as a heat source
Achieva 3.0T MR systems are being recalled because component failures in the gradient coil may act as a heat source with the potential to produce smoke or fire. 460 units are affected.
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: Risk-of-harm product: a component that may produce smoke or fire in a scanner enclosing a patient, with no injury reported in the source.
Plain-English summary
The Achieva 3.0T MR system, model numbers 781177, 781277, 781278, 781344 and 781345, is being recalled. The action covers 460 units, identified by the serial numbers in the recall notice.
The stated reason is the potential for component failures in the gradient coil of the affected MR systems, which may act as a heat source with a potential to produce smoke and/or fire. The FDA classified the action as Class II. The source does not report any injury having occurred.
Distribution was worldwide, including nationwide in the United States and to Albania, Algeria and Angola among other markets. The systems are installed in healthcare facilities rather than sold to consumers.
Facilities should identify affected systems using the model numbers and serial numbers above and follow the instructions issued by the manufacturer.
The recalled product
- Product
- Achieva 3.0T; Model Numbers (REF): (1) 781177, (2) 781277, (3) 781278, (4) 781344, (5) 781345;
- Manufacturer
- Philips North America
- Category
- Medical Device — MRI system
- Affected units
- 460
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) 781177
- (2) 781277
- (3) 781278
- (4) 781344
- (5) 781345
- UDI-DI: (1) None
- (2) None
- (3) 00884838004139
- (4) None
- (5) None
- Serial Numbers: (1) 17008
- 17011
- 17017
- 17030
- 17035
- 17038
- 17039
- 17043
- 17049
- 17051
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 19 recalled by Philips North America under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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