Optima Mr360 1.5t (2018-11-19)

Summary GE Healthcare's Optima MR360 1.5T magnetic resonance imaging (MRI) machines sold in Canada from November 2018 onward are being recalled due to a device defect. This is a Class I recall, meaning there is a serious risk of injury or death. The recall affects MRI systems distributed across Canada.

Reason

Medical devices

Classification

Class I

Category

drug recall

Country

Canada

Agency

HC-DEVICES

Recall date

2018-11-30

Status

Ongoing

Distribution

Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/6d3e428f-0bf9-4053-aa21-858a7bb4ee1a