FDA-Device2018-12-26Class II
Carousel MAS1025-01, part of the Brain Surgical Accessories Intra-operative Kit (KIT0295), accessory used with the Renaissance System (TPL0038). Indicated for precise positioning of surgical instruments or spinal implants during general spinal and brain surgery. It is intended to be used whenever the clinician and/or patient benefits from generated 3D imaging of, high contrast objects.
Mazor Robotics Ltd
Hazard
In some situations the carousel position pin (locker) may cause the carousel upper plate to pop out and the carousel may then inadvertently move.
Sold states
Affected devices were distributed in the US to four different medical facilities in four states
Affected count
5 units
Manufactured in
5 Shacham Street, P.O. Box 3104, North Industrial Park, Israel
Products
Carousel MAS1025-01, part of the Brain Surgical Accessories Intra-operative Kit (KIT0295), accessory used with the Renaissance System (TPL0038). Indicated for precise positioning of surgical instruments or spinal implants during general spinal and brain surgery. It is intended to be used whenever the clinician and/or patient benefits from generated 3D imaging of, high contrast objects.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0609-2019Don't want to check this manually?
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