Safety
Globus recalled 9 kits of an add-on part used with ExcelsiusGPS for X-ray imaging, because a calibration error could make the navigation inaccurate and a screw could be placed in the wrong spot. The FDA listed it as a Class 1 recall (its most serious kind).
A crash, recall, injury or investigation
What the source says
“A calibration error associated with the Flat Panel Fluoroscopy Fixture when used with ExcelsiusGPS for fluoroscopy workflow may lead to inaccurate navigation, which may result in device misplacement.”
What it means
ExcelsiusGPS, from Globus Medical, 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 ExcelsiusGPS
- The FDA cleared a sister robot, ExcelsiusFlex, for knee replacement and other joint surgery.
- Globus said surgeons had done more than 20,000 spine operations with ExcelsiusGPS.
- The first European operation with ExcelsiusGPS took place at Metropolitan Hospital in Athens, Greece.
- The FDA cleared ExcelsiusGPS through the 510(k) route (K171651) for open and minimally invasive spine and orthopedic surgery.
- Globus began selling ExcelsiusGPS in the US at the end of 2017.