Mazor Robotics recalled 549 Mazor X robotic guidance systems on December 10, 2025, due to software errors. These errors may cause incorrect surgical instrument positioning during spinal surgeries. Patients and healthcare providers must stop using the device immediately.
Software errors that can result in incorrect surgical instrument positioning during spinal surgery.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Mazor Robotics Ltd or your healthcare provider for instructions. Notification method: Letter
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The Mazor X robotic guidance system assists surgeons in performing spinal surgeries with enhanced precision. Healthcare providers use this device to improve outcomes and reduce risks during complex procedures.
The software errors in the Mazor X guidance system can lead to incorrect positioning of surgical instruments, potentially compromising surgical accuracy and patient safety.
This recall is not part of a broader industry pattern.
Patients and healthcare providers must take immediate action to avoid serious surgical risks. The recall may disrupt surgical schedules and affect patient treatment plans.
The software version can usually be found in the system's settings or user manual.
Expect a response regarding your recall inquiry within 4-6 weeks.
Keep records of your purchase, any correspondence with the manufacturer, and notes on your system's software version.
The recall affects Mazor X robotic guidance systems with software versions 5.0.1, 5.1.2, and 5.1.3. These systems were distributed worldwide, including in the United States, Canada, and several European countries. The systems are classified as Class II medical devices.
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