Rt Elements - Multiple Brain Mets Srs, Cranial Srs, Spine Srs, Rt Qa (2019-03-26)

Recall Summary RT Elements software used for radiation therapy planning in brain, spine, and quality assurance procedures has been recalled across Canada due to a medical device issue. The software is used by hospitals and treatment centers to plan stereotactic radiosurgery treatments. The recall affects all units of this software that were distributed in Canada.

Reason

Medical devices

Classification

Class I

Category

drug recall

Country

Canada

Agency

HC-DEVICES

Recall date

2019-05-03

Status

Ongoing

Distribution

Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/b79c6219-5804-4c69-a77a-853241a69470