Philips Ingenia 3.0T gradient coils may act as a heat source
Ingenia 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. 1,467 units are affected.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 Ingenia 3.0T MR system, model numbers 781342, 781377 and 782103, is being recalled. The action covers 1,467 units, identified by the UDI-DI codes and 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, UDI-DI codes and serial numbers above and follow the instructions issued by the manufacturer.
The recalled product
- Product
- Ingenia 3.0T Model Numbers (REF): (1) 781342, (2) 781377, (3) 782103;
- Manufacturer
- Philips North America
- Category
- Medical Device — MRI system
- Affected units
- 1,467
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) 781342
- (2) 781377
- (3) 782103
- UDI-DI: (1) 00884838055339
- (2) 00884838009813
- (3) 00884838098299
- Serial Numbers: (1) 71001
- 71002
- 71003
- 71004
- 71006
- 71007
- 71008
- 71010
- 71011
- 71012
- 71013
- 71014
- 71016
- 71018
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.
See all 19 products in this recall →Related recalls
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