Estiva/5 Mri System (2019-07-25)

Aestiva/5 MRI System Recall Summary The Aestiva/5 MRI System is being recalled in Canada due to a safety issue with the medical device. This recall affects all units of this MRI system that were distributed across Canada. The FDA has classified this as a Class I recall, which is the most serious type.

Reason

Medical devices

Classification

Class I

Category

drug recall

Country

Canada

Agency

HC-DEVICES

Recall date

2019-08-09

Status

Ongoing

Distribution

Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/ceb673dd-af7d-418f-ab84-957967b08c45