Mazor Robotics Ltd: Mazor X robotic guidance system REF: TPL0059

Hazard

Software errors that can result in incorrect surgical instrument positioning during spinal surgery.

Details from the source

Reason for recall: Software errors that can result in incorrect surgical instrument positioning during spinal surgery. Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Brazil, Canada, Canary Islands, China, Croatia, France, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Japan, Malaysia, Mexico, Netherlands, Poland, Portugal, Puerto Rico, Romania, Singapore, Slovakia, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Arab Emirates, United Kingd Quantity: 549 systems Lot/code info: Software versions: 5.0.1, 5.1.2, 5.1.3/ UDI: 07290109180465, 07290109184524, 07290109181158, 00763000635169, 07290109183213, 07290109184517, 00763000419134, 00763000431761, 07290109184098, 07290109184838, 07290115751376, 07290115751895

UPC codes

07290109180465, 07290109184524, 07290109181158, 00763000635169, 07290109183213, 07290109184517, 00763000419134, 00763000431761, 07290109184098, 07290109184838, 07290115751376, 07290115751895

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.