# Major Recall Alert: Mazor™ X System Recall Due to Critical Software Anomalies in Version 5.2
The Mazor™ X System, a renowned robotic system designed for spinal surgery, is currently under recall due to critical issues identified in its latest software update, version 5.2. While this update resolves 111 anomalies from prior software versions (5.0.1, 5.1.2, and 5.1.3), 7 of these were found to involve observed or potential harm greater than negligible. This concerning development has prompted swift action to ensure patient safety.
If you or your medical facility utilizes the Mazor™ X System, here’s everything you need to know about this recall and how to protect patients and staff.
## Why This Recall is Important
Medical software updates like Mazor software version 5.2 are integral to the performance and safety of systems like the Mazor™ X System. Although the update addressed over 100 anomalies from previous versions, seven of these newly identified issues raise significant safety concerns. These anomalies could pose risks beyond negligible harm, potentially impacting the system’s performance during critical medical procedures such as spinal surgeries.
It’s worth noting that due to the precision and complexity demanded for procedures aided by the Mazor™ X System, any potential software malfunction—even a minor one—has the potential to lead to serious complications or delays in patient care.
## Details of the Recall
- **Product Name**: Mazor™ X System
- **Category**: Medical Device – Software Update (Version 5.2)
- **Brands Affected**: Mazor™
- **Reason for Recall**:
- Of the 111 resolved anomalies in software version 5.2:
- **104 anomalies** are evaluated as posing no harm or negligible risk.
- **7 anomalies** have been identified with observed or potential harm greater than negligible, necessitating this recall.
- **Date Announced**: October 9, 2023
- **Relevant Software Versions**: Prior updates (5.0.1, 5.1.2, 5.1.3), as well as version 5.2.
For more details, refer to the official recall announcement here: [Official Recall Notice](https://recalls-rappels.canada.ca/en/alert-recall/mazortm-x-system-0).
### Safety Measures Taken by Mazor
- Immediate assessment of the software anomalies diagnosed in Version 5.2 to mitigate risks.
- Communication to healthcare professionals and users of the Mazor™ X System regarding the recall and the risks associated with continuing to use the affected software.
- Guidance on reverting to a safer software version or implementing necessary updates.
## What You Should Do
If your facility operates the Mazor™ X System, here are the immediate steps you should take:
- **Cease Use of Software Version 5.2:** If you are using this version, stop immediately and consult the manufacturer for the next steps.
- **Contact the Manufacturer:** Reach out to Mazor Robotics (or the device distributor) for assistance in downgrading software or obtaining further guidance on mitigating risks.
- **Review Surgical Schedules:** Ensure any procedures planned with the Mazor™ X System are reassessed until the system is deemed safe and ready for use.
- **Stay Updated:** Frequently check for updates from the manufacturer or local regulatory agencies about progress and resolution of this issue.
## Stay Safe – Get Instant Recall Alerts
Keeping track of medical recalls like the Mazor™ X System is critical for patient safety. Don’t let important updates like this slip through the cracks. Download the [MyRecalls App](https://myrecalls.app) today to receive instant alerts on product recalls in your industry or household.
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Don’t wait—stay informed so you can act quickly in protecting those who depend on you.
For the latest information on this recall, visit the official Health Canada link: [Mazor™ X System Recall Notice](https://recalls-rappels.canada.ca/en/alert-recall/mazortm-x-system-0).
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By staying informed and proactive, we can ensure the highest standard of care and safety in medical facilities worldwide. Share this information with your network to help raise awareness.