Rosa One 3.1 Brain (2021-09-22)

ROSA One 3.1 Brain Recall Summary The ROSA One 3.1 Brain surgical robotic system is being recalled across Canada due to a medical device issue. This recall affects healthcare facilities that use this robotic surgical system for brain procedures. The recall is classified as Class I, indicating a serious potential health risk.

Reason

Medical devices

Classification

Class I

Category

drug recall

Country

Canada

Agency

HC-DEVICES

Recall date

2021-09-28

Status

Ongoing

Distribution

Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/3de33817-70b4-4234-9874-b921e8cb6b29