Mazor™ X System
Brand(s)
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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