The Recall Desk
HighFDA (Devices)·Z-1431-2018·Announced 2018-04-25

Philips Intera 0.5T MRI Recalled for Helium Gas Risk

Philips is recalling 8,205 Intera 0.5T MRI scanners worldwide due to a potential risk of helium gas release during a magnet quench.

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: The recall is classified as FDA Class II and involves a risk-of-harm product (asphyxiation hazard from helium) where specific injury reports are not detailed in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.

Plain-English summary

Philips Electronics North America Corporation is recalling 8,205 units of the Intera 0.5T Standard MRI scanner, Model 781101. These diagnostic devices are indicated for producing cross-sectional and spectroscopic images of the head, body, or extremities. The recall is due to a potential risk of helium gas inside the MR examination room during a magnet quench.

The affected units were distributed worldwide, including across the United States and numerous international locations. The recall was classified as Class II by the U.S. Food and Drug Administration. Specific lot numbers or serial codes were added to the recall record on June 25, 2018.

Healthcare facilities and users of these devices should contact Philips Electronics North America Corporation for further instructions on how to address the potential hazard. The source text does not specify the exact steps for mitigation or the current status of the recall beyond the initial classification.

The recalled product

Product
Intera 0.5T Standard, Model 781101 Product Usage: Indicated for use as a diagnostic device. It can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body,or extremities.
Manufacturer
Philips Electronics North America Corporation
Category
Medical Device — Magnetic Resonance Imaging (MRI)
Hazard
Affected units
8,205

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 (1)

  • (Added 6/25/18): 6051 6003 6046 6004

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 13 recalled by Philips Electronics North America Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 13 products in this recall →

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