The Recall Desk
HighFDA (Devices)·Z-2342-2021·Announced 2021-09-01

Philips Ingenia MRI System recalled due to incorrect pressure relief valve

Philips recalled 27 units of the Ingenia 1.5T Magnetic Resonance system with an incorrect pressure relief valve (42 psi instead of 3.75 psi) that could release helium gas and cause 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: FDA Class II recall of a medical device with a component defect that may cause helium gas release and injury. No injuries or illnesses have been reported. Per the FDA severity rubric, risk-of-harm products without reported injuries are classified as High (score 3).

Plain-English summary

Philips North America LLC has recalled the Ingenia 1.5T Magnetic Resonance Medical Electrical System, a diagnostic imaging device used in medical settings. The recall affects 3 units distributed in the United States and 24 units distributed internationally across multiple countries.

The recall was initiated due to a component defect in the magnet assembly. A pressure relief valve rated at 42 psi was installed instead of the specified 3.75 psi valve.

This defect may result in unintended release of helium gas from the system, which could potentially cause injury to patients or medical personnel.

The recalled product

Product
Ingenia 1.5T-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 — Magnetic Resonance Imaging
Hazard
  • gas-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: 84344 (01)00884838055322(21)84344
  • 87019 (01)00884838055322(21)87019

Distribution

Distributed nationwide across the United States.

Related recalls

Same category