Philips Intera 1.5T MRI Systems Recalled for Helium Gas Risk
Philips is recalling Intera 1.5T MRI systems due to a potential risk of helium gas release during a magnet quench.
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: The recall involves a risk-of-harm product (MRI system) where injury has not yet been reported, fitting the 'High' severity criteria for theoretical hazards.
Plain-English summary
Philips Electronics North America Corporation is recalling specific models of the Intera 1.5T MRI system. The recall involves 8,205 units distributed worldwide, including the United States and numerous international locations.
The recall is issued because of a potential risk for helium gas inside the MR examination room during a magnet quench. A magnet quench is a rapid loss of the magnetic field, which can result in the release of helium gas.
Healthcare facilities and consumers with these devices should contact Philips for instructions on how to proceed with the recall and any necessary corrective actions.
The recalled product
- Product
- Intera 1.5T; 1) Intera 1.5T Omni/Stellar Model 781104, 2) Intera 1.5T Power/Pulsar Model 781105, 3) Intera 1.5T Master/Nova Model 781106, 4) Intera 1.5T Master CV Model 781107, 5) Intera 1.5T Explorer/ Nova Dual Model 781108, 6) Intera 1.5T IT Model 781160, 7) Intera 1.5T…
- Manufacturer
- Philips Electronics North America Corporation
- Category
- Medical Device — MRI Scanner
- Hazard
- Affected units
- 8,205
Distribution
Part of a larger recall action
This product is one of 13 recalled by Philips Electronics North America Corporation 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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