Ultrasound Integration Software For Cranial/ent Navigation 3.1.x (2020-08-31)

Recall Summary Ultrasound Integration Software for Cranial/ENT Navigation version 3.1.x (released August 31, 2020) is being recalled across Canada. The software has a defect that could affect the accuracy of ultrasound guidance during cranial and ear, nose, and throat surgical navigation procedures. This is classified as a Class I recall, the most serious category, and affects medical facilities using this software version.

Reason

Medical devices

Classification

Class I

Category

drug recall

Country

Canada

Agency

HC-DEVICES

Recall date

2021-07-29

Status

Ongoing

Distribution

Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/691aca4a-38cd-4277-b47a-7ef289ff8542