Health product recall

Mazor™ X System

Last updated

Summary

Product
Mazor™ X System
Issue
Medical devices - Performance
What to do

Contact the manufacturer if you require additional information. 

Audience
Healthcare

Affected products

Affected products

Lot or serial number

Model or catalogue number

Mazor™ X System

4004121121

TPL0059

Mazor™ X System

4006550623

TPL0059

Mazor™ X System

4005601222

TPL0059

Mazor™ X System

4006110323

TPL0059

Mazor™ X System

4003770621

TPL0059

Mazor™ X System

4007070124

TPL0059

Issue

Mazor software version 5.2 is an update to any prior software version, including software versions 5.0.1, 5.1.2, and 5.1.3. Of the 111 resolved anomalies within software version 5.2, 104 are evaluated as representing no or negligible harm. 7 are evaluated with observed or potential harm greater than negligible.

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Orthopaedics
Companies

Mazor Robotics Ltd.

1 Haeshel Street Building C, Caesarea Hefa, Israel, 3079830

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Recall date
Identification number
RA-81382

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