The Recall Desk
HighFDA (Devices)·Z-1430-2018·Announced 2018-04-25

Philips Multiva MRI Systems Recalled for Helium Gas Risk During Quench

Philips is recalling 8,205 Multiva MRI systems worldwide due to a potential risk of helium gas release in the examination room 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 involves a risk-of-harm product (asphyxiation hazard from helium gas) where injury has not yet been reported, which aligns with the 'High' severity criteria.

Plain-English summary

Philips Electronics North America Corporation is recalling 8,205 units of Multiva MRI systems, including models 781072, 781073, 781074, 781076, and 781078. These diagnostic devices are indicated for producing cross-sectional images, spectroscopic images, and/or spectra of the internal structure of the head, body, or extremities.

The recall is due to a potential risk for 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 source text does not specify the corrective actions consumers or healthcare facilities should take, nor does it report any specific injuries or illnesses associated with this defect.

The recalled product

Product
Multiva systems, 1) Multiva 1.5T 8 R5 Model 781072, 2) Multiva 1.5T 16 R5 Model 781073, 3) Multiva 1.5T 8ch R5 based Model 781074, 4) Multiva 1.5T Model 781076, & 5) Multiva 1.5T 16ch R5 based Model 781078 Product Usage: Indicated for use as a diagnostic device. It can produ
Manufacturer
Philips Electronics North America Corporation
Category
Medical Device — MRI Systems
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)

  • None

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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