The Recall Desk
SevereFDA (Devices)·Z-1927-2016·Announced 2016-06-15

GE Healthcare Recalls MSK 1.5T Extreme MR Scanners Due to Gas Venting Defect

GE Healthcare is recalling 97 MSK 1.5T Extreme MR Scanners because gas venting may not occur properly, posing a risk of oxygen deprivation.

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 describes a hazard that could cause 'critical deprivation of oxygen' to users and patients, which constitutes a risk of serious injury or death, aligning with the 'Severe' criteria for significant injury reports or high-risk structural defects.

Plain-English summary

GE Healthcare, LLC is recalling 97 units of the MSK 1.5T Extreme MR Scanner, a diagnostic imaging device. The recall was initiated because the gas venting system may not function properly. A site reported a magnet quenching event where cryogen gas vented into the magnet room.

The hazard associated with this defect is that cryogen gas venting into the magnet room could cause critical deprivation of oxygen to users and patients. The affected units were distributed across 26 U.S. states and 31 countries outside the United States.

Consumers and healthcare facilities should contact GE Healthcare for instructions on how to address the defect. The specific serial numbers and system IDs for the affected units are listed in the official recall documentation.

The recalled product

Product
MSK 1.5T Extreme MR Scanner, a diagnostic imaging device
Manufacturer
GE Healthcare, LLC
Affected units
97

Distribution

Part of a larger recall action

This product is one of 2 recalled by GE Healthcare, LLC 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 2 products in this recall →