The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2345-2021·Announced 2021-09-01

MRI System Pressure Valve Installation Error Poses Helium Release Risk

A wrong pressure relief valve was installed in Ingenia CX 3.0T MRI systems, which may release helium gas and cause injury to patients and staff.

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 medical device recall with an installation defect (wrong pressure relief valve) that could result in helium gas release and injury. No injuries have been reported. Meets the rubric criterion for 'risk-of-harm products where injury has not yet been reported.'

Plain-English summary

Philips North America LLC is recalling 11 Ingenia CX 3.0T magnetic resonance imaging (MRI) systems. The recalled systems were distributed worldwide to medical facilities in multiple U.S. states and countries.

An incorrect pressure relief valve was installed in the magnet assembly of these systems. Instead of the required 3.75 psi valve, a 42 psi valve was installed. This defect could result in the unintended release of helium gas, which may cause injury to patients or medical personnel.

The affected systems were distributed throughout the United States (including Alabama, Arizona, Arkansas, California, Colorado, Maryland, New Hampshire, New York, Ohio, Tennessee, Texas, and Virginia) and internationally to Canada, Mexico, Australia, Austria, Chile, China, Czech Republic, Denmark, France, Germany, India, Indonesia, Italy, Japan, Korea, Lebanon, Netherlands, Romania, Russian Federation, Saudi Arabia, Spain, Turkey, Ukraine, and the United Kingdom.

Healthcare facilities should immediately cease use of affected systems and contact the manufacturer for corrective action or device replacement.

The recalled product

Product
Ingenia CX 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…
Manufacturer
Philips North America Llc
Category
Medical Device
Hazard
Affected units
11

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 (11)

  • S/N and UDI: 78189 (01)00884838068452
  • 78272 (01)00884838068452
  • 78294 (01)00884838068452
  • 78295 (01)00884838068452
  • 78332 (01)00884838068452
  • 78335 (01)00884838068452
  • 78340 (01)00884838068452
  • 78345 (01)00884838068452
  • 78249 (01)00884838068452
  • 78324 (01)00884838068452
  • 78326 (01)00884838068452

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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