MRI System Pressure Valve Installation Error Poses Helium Release Risk

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 Number

Manufacturer

Philips North America Llc

Category

Medical Device

Hazard

• helium-gas-release
• burn-injury
• pressure-relief-failure

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

Distributed nationwide across the United States.

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