The Recall Desk
HighFDA (Devices)·Z-2344-2021·Announced 2021-09-01

Philips Ingenia MRI System Equipped With Incorrect Pressure Relief Valve

Philips Ingenia Elition X MRI systems contain an incorrectly installed pressure relief valve that may release helium gas and cause injury. The recall affects 6 U.S. units and 12 units distributed internationally.

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 involving a component installation defect that may cause helium gas release and injury. Since no illnesses, hospitalizations, or injuries have been reported and the hazard is theoretical rather than realized, the severity is rated High per the rubric.

Plain-English summary

Philips has recalled certain Ingenia Elition X-Magnetic Resonance (MRI) systems. These systems are indicated for diagnostic use and can produce cross-sectional and spectroscopic images of internal body structures.

The systems contain an incorrectly installed pressure relief valve in the magnet assembly. A 42 psi pressure relief valve was installed instead of the correct 3.75 psi valve. This defect may result in the release of helium gas, which could cause injury to patients or healthcare workers near the equipment.

The recall affects 6 units distributed in the United States across multiple states and 12 units distributed internationally in 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.

The recalled product

Product
Ingenia Elition X-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 — Diagnostic Imaging
Hazard
  • pressure-valve-defect
  • helium-release
  • injury-risk

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 (20)

  • S/N and UDI: US: 45245 (01)00884838088115(21)45245
  • 45247 (01)00884838088115(21)45247
  • 45261 (01)00884838088115(21)45261
  • 45263 (01)00884838088115(21)45263
  • 45264 (01)00884838088115(21)45264
  • 45269 (01)00884838088115(21)45269
  • OUS: 45215 (01)00884838088115
  • 45284 (01)00884838088115
  • 45253 (01)00884838088115
  • 45313 (01)00884838088115
  • 45265 (01)00884838088115
  • 45297 (01)00884838088115
  • 45218 (01)00884838088115
  • 45272 (01)00884838088115
  • 45281 (01)00884838088115
  • 45231 (01)00884838088115
  • 45278 (01)00884838088115
  • 45279 (01)00884838088115
  • 45245 (01)00884838088115
  • 45247 (01)00884838088115

Distribution

Distributed nationwide across the United States.

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