MRI System Pressure Relief Valve Installation Error May Release Helium Gas
Philips MRI systems may have incorrect pressure relief valves installed, risking helium gas release and injury. Seven units contain 42 psi valves instead of required 3.75 psi valves.
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: This FDA Class II recall involves a safety-critical component in medical equipment with potential for helium gas release and injury. However, no illnesses or injuries have been reported in the source, and the hazard remains theoretical. Per the severity rubric, when no injuries are reported and the hazard is theoretical, the maximum score is 3.
Plain-English summary
Philips Ingenia Elition S-Magnetic Resonance systems may have an incorrect pressure relief valve installed in the magnet assembly. The systems are equipped with 42 psi pressure relief valves instead of the specified 3.75 psi valves. This error may result in uncontrolled helium gas release and potential injury.
Seven units have been identified with this defect and have been distributed worldwide, including in the United States, Canada, Mexico, Australia, and multiple other countries across Europe, Asia, the Middle East, and beyond.
The recalled product
- Product
- Ingenia Elition S-Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body or extremities Model…
- Manufacturer
- Philips North America Llc
- Affected units
- 7
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 (7)
- S/N and UDI: 46083 (01)00884838088108
- 46084 (01)00884838088108
- 46086 (01)00884838088108
- 46054 (01)00884838088108
- 46058 (01)00884838088108
- 46082 (01)00884838088108
- 46061 (01)00884838088108
Distribution
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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