The Recall Desk
HighFDA (Devices)·Z-2347-2021·Announced 2021-09-01

MRI System Pressure Relief Valve Installation Error May Release Helium Gas

Philips MRI systems may have incorrect pressure relief valves installed, risking helium gas release and injury. Seven units contain 42 psi valves instead of required 3.75 psi valves.

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 FDA Class II recall involves a safety-critical component in medical equipment with potential for helium gas release and injury. However, no illnesses or injuries have been reported in the source, and the hazard remains theoretical. Per the severity rubric, when no injuries are reported and the hazard is theoretical, the maximum score is 3.

Plain-English summary

Philips Ingenia Elition S-Magnetic Resonance systems may have an incorrect pressure relief valve installed in the magnet assembly. The systems are equipped with 42 psi pressure relief valves instead of the specified 3.75 psi valves. This error may result in uncontrolled helium gas release and potential injury.

Seven units have been identified with this defect and have been distributed worldwide, including in the United States, Canada, Mexico, Australia, and multiple other countries across Europe, Asia, the Middle East, and beyond.

The recalled product

Product
Ingenia Elition S-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 Numb
Manufacturer
Philips North America Llc
Category
Medical Device — Magnetic Resonance Imaging
Hazard
  • pressure-relief-valve-defect
  • helium-release
  • burn-injury

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 (7)

  • S/N and UDI: 46083 (01)00884838088108
  • 46084 (01)00884838088108
  • 46086 (01)00884838088108
  • 46054 (01)00884838088108
  • 46058 (01)00884838088108
  • 46082 (01)00884838088108
  • 46061 (01)00884838088108

Distribution

Distributed nationwide across the United States.

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