The Recall Desk
SevereFDA (Devices)·Z-1188-2017·Announced 2017-02-22

GE Healthcare Recalls Discovery MR450 MRI Scanners Due to Burn Risk

GE Healthcare is recalling 60 Discovery MR450 MRI scanners because a component failure can cause the patient bore to heat up, potentially leading to serious burns.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The source text explicitly states that the hazard 'may cause a serious burn,' which aligns with the rubric criterion for 'significant injury' reports, warranting a score of 4.

Plain-English summary

GE Healthcare, LLC is recalling 60 units of the Discovery MR450 whole body magnetic resonance scanners. These devices are used for diagnostic imaging of various body parts. The recall is due to a potential safety issue where the patient bore may heat up abnormally.

The hazard occurs if a radio frequency (RF) component fails, typically after extended system use. In this scenario, a small area on the bore surface may become warmer than normal. If a patient is in contact with this area and proper padding is not used, it may cause a serious burn.

The affected units were distributed worldwide, including in the United States and several international countries. Healthcare facilities should contact GE Healthcare for instructions on how to address this issue.

The recalled product

Product
Discovery MR450 The systems are whole body magnetic resonance scanners designed to support high resolution, high signal-to-noise ratio, and short scan times. It is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images, spectro
Manufacturer
GE Healthcare, LLC
Affected units
60

Distribution

Distributed nationwide across the United States.

The notice also names 10 states specifically: