The Recall Desk
HighFDA (Devices)·Z-2343-2021·Announced 2021-09-01

Diagnostic MRI system recalled for pressure relief valve defect

A Philips Ingenia MRI system has been recalled due to installation of a 42 psi pressure relief valve instead of the correct 3.75 psi valve, which may result in helium gas release and injury.

What this means for you

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 functional defect that may release helium gas and cause injury. No hospitalizations or injuries have been reported; the hazard is theoretical. This fits the High severity category for risk-of-harm products without documented injuries.

Plain-English summary

Philips North America LLC is recalling the Ingenia 3.0T Magnetic Resonance Imaging System, a diagnostic medical device used to produce cross-sectional and spectroscopic images of the head, body, and extremities.

The recalled devices contain a 42 psi pressure relief valve installed in the magnet assembly instead of the correct 3.75 psi valve. This defect may result in release of helium gas and cause injury.

Three units have been identified in the United States across multiple states, including Alabama, Arizona, Arkansas, California, Colorado, Maryland, New Hampshire, New York, Ohio, Tennessee, Texas, and Virginia. Additionally, 17 units have been distributed outside the United States in countries including Canada, Mexico, Australia, Austria, Chile, China, Czech Republic, Denmark, France, Germany, India, Indonesia, Italy, Japan, Korea, Lebanon, Netherlands, Romania, Russia, Saudi Arabia, Spain, Turkey, Ukraine, and the United Kingdom.

This is an FDA Class II recall (number Z-2343-2021). The specific serial numbers of affected units are documented in the official FDA recall notice.

The recalled product

Product
Ingenia 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: 7
Manufacturer
Philips North America Llc
Category
Medical Device — Diagnostic Imaging / MRI
Hazard
  • helium-release
  • valve-defect

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 (2)

  • S/N and UDI: 85275 (01)00884838055339(21)85275
  • 85278 (01)00884838055339(21)85278

Distribution

Distributed nationwide across the United States.

Related recalls

Same category