Safety
Class 2 FDA recall of the Mazor X system: software errors could lead to wrong tool position in spine surgery. 549 systems affected.
A crash, recall, injury or investigation
What the source says
“Software errors that can result in incorrect surgical instrument positioning during spinal surgery.”
What it means
Mazor X Stealth Edition, from Medtronic (originally Mazor Robotics, Israel), is at stage 5 of 5 on our ladder: regulator-cleared or mass market. Safety events don't move a stage on their own, but they stay on the robot's record.
Human help: Our sources report it working without human help.
More on Mazor X Stealth Edition
- The FDA cleared Medtronic's newer Stealth AXiS system through the 510(k) route. It puts surgery planning, navigation and robotics in one spine platform.
- Medtronic started a Class 2 recall of the Mazor X system over software errors that can put surgical tools in the wrong position. The FDA record lists 549 systems.
- Medtronic warned that some Mazor X robots could come loose from the operating table and fall. It had seven complaints and no reported injuries.
- Medtronic launched the Mazor X Stealth Edition in the US, and it began treating its first US patients.
- Before the Stealth Edition, Mazor already sold the Mazor X guidance system and an older spine robot called Renaissance.
- Medtronic completed its purchase of Israel-based Mazor Robotics for about $1.7 billion. Medtronic had already bought a 10.6% stake in stages.