Intera 1.5T MRI System Recall: Gradient Coil Fire Risk
Philips is recalling the Intera 1.5T Power/Pulsar MRI system due to potential failure in the gradient coil component that could produce smoke and/or fire.
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: FDA Class II recall for a medical device with potential for fire and smoke due to component failure. Although the hazard is serious, no illnesses or injuries have been reported, and the risk is described as potential rather than confirmed, placing this in the High category per the rubric.
Plain-English summary
Philips North America Llc is recalling the Intera 1.5T Power/Pulsar MRI system. The recalled device is affected by a potential component failure in the gradient coil, which could produce smoke and/or fire.
The recall affects the Intera 1.5T Power/Pulsar (Product No. 781105, Serial No. 8187) distributed nationwide in the United States and internationally across 56+ countries including Canada, the United Kingdom, Japan, Australia, and many others.
Healthcare facilities and medical professionals with the affected device should contact Philips North America Llc for instructions regarding the gradient coil component and appropriate mitigation measures. No illnesses or injuries have been reported to date related to this potential component failure.
The recalled product
- Product
- Intera 1.5T Power/Pulsar
- Manufacturer
- Philips North America Llc
- Category
- Medical Device — MRI System
- Affected units
- 1
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 (3)
- Product No. 781105
- UDI-DI: N/A
- Serial No. 8187.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 7 recalled by Philips North America Llc 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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