CanadaThe Mazor X System (model TPL0059; serial/lot numbers 4004121121, 4006550623, 4005601222, 4006110323, 4003770621, 4007070124) running or updated to Mazor software version 5.2 is affected. Software version 5.2 includes 111 resolved anomalies, 7 of which are evaluated with observed or potential harm greater than negligible; contact the manufacturer for additional information.
What's being recalled
Companies: Mazor Robotics Ltd., 1 Haeshel Street Building C, Caesarea Hefa, Israel, 3079830.
How to identify it
Affected products: Mazor™ X System; Lot or serial number: 4004121121; Model or catalogue number: TPL0059
Affected products: Mazor™ X System; Lot or serial number: 4006550623; Model or catalogue number: TPL0059
Affected products: Mazor™ X System; Lot or serial number: 4005601222; Model or catalogue number: TPL0059
Affected products: Mazor™ X System; Lot or serial number: 4006110323; Model or catalogue number: TPL0059
Affected products: Mazor™ X System; Lot or serial number: 4003770621; Model or catalogue number: TPL0059
Affected products: Mazor™ X System; Lot or serial number: 4007070124; Model or catalogue number: TPL0059
The hazard
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.
What to do
Contact the manufacturer if you require additional information.
The official notice
This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.
Read the official notice (opens in a new tab)