The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2346-2021·Announced 2021-09-01

MRI System Pressure Relief Valve Defect May Cause Helium Release

Philips Achieva 3.0T MRI systems may have an incorrectly installed pressure relief valve that could release helium gas and cause injury. Affected units are distributed in the United States and internationally.

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 of a risk-of-harm medical device. The hazard—potential helium gas release causing injury—is explicitly stated in the source, but no illnesses, injuries, or hospitalizations are reported. This qualifies as High severity per the rubric criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Philips North America LLC is recalling Achieva 3.0T Magnetic Resonance (MRI) systems used as diagnostic devices to produce cross-sectional images of the head, body, and extremities.

The recalled system contains a pressure relief valve rated at 42 psi that was installed in the magnet assembly. The system should have a 3.75 psi pressure relief valve. This incorrect valve installation may result in the release of helium gas and could cause injury.

The affected unit has been distributed worldwide, including in the United States and multiple countries. U.S. distribution includes Alabama, Arizona, Arkansas, California, Colorado, Maryland, New Hampshire, New York, Ohio, Tennessee, Texas, and Virginia. International distribution includes Canada, Mexico, Australia, Austria, Chile, China, Czech Republic, Denmark, France, Germany, India, Indonesia, Italy, Japan, Korea, Lebanon, Netherlands, Romania, the Russian Federation, Saudi Arabia, Spain, Turkey, Ukraine, and the United Kingdom.

Healthcare facilities should contact Philips North America LLC to verify whether their unit is affected and to arrange for correction of the pressure relief valve.

The recalled product

Product
Achieva 3.0T-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 Number…
Manufacturer
Philips North America Llc
Category
Medical Device — Diagnostic Imaging
Hazard
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 (1)

  • S/N and UDI: N/A

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 →

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