Agency classClass IIOur severity:High FDA (Devices)·Z-2341-2021·Announced 2021-09-01

MRI System Pressure Relief Valve Defect May Release Helium Gas

Philips MRI systems contain an incorrectly rated pressure relief valve that may release helium gas and cause injury. The system was installed with a 42 psi valve instead of the required 3.75 psi valve.

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 is an FDA Class II recall of a medical device with a risk-of-harm hazard (helium gas release potentially causing injury). No hospitalizations, illnesses, or injuries have been reported. Per the severity rubric, risk-of-harm products where injury has not yet been reported score at most 3 (High).

Plain-English summary

Philips is recalling specific units of Ingenia 1.5T Evoluton MRI systems due to a pressure relief valve defect. The magnet assembly in these devices contains a 42 psi pressure relief valve instead of the correct 3.75 psi valve.

The incorrect valve rating may cause the pressure relief system to function improperly and allow helium gas to be released from the system unexpectedly. This could potentially cause injury to patients or operators in proximity to the device.

The recall affects 2 units in the United States and 16 units internationally across multiple countries. Healthcare facilities with affected MRI systems should verify their device serial numbers and contact Philips for guidance on corrective actions.

The recalled product

Product: Ingenia 1.5T Evoluton- 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
Category: Medical Device — MRI System
Hazard: valve-defect
helium-release

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 (1)

S/N and UDI: US: 61044 (01)00884838099715(21)61044

Distribution

Distributed nationwide across the United States.

The notice also names 12 states specifically:

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.

See all 7 products in this recall →

Same manufacturer · Philips North America Llc

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Same hazard · valve defect