FDA-Device2016-06-22Class II
Protura Robotic Couch System Software, versions 1.6.1 (Part Number MT6XSM1.6.1), 1.7.0 (Part Number MT6XSM1.7.0), and 1.7.1 (Part Number MT6XSM1.7.1), CIVCO, Orange City, IA 51041
Med Tec Inc
Hazard
When using the recalled product in split shift mode, the non-sub-millimeter positioning has been found to be inconsistent with the setting parameters.
Sold states
Worldwide Distribution - US Distribution including the countries of Switzerland, Germany..
Affected count
9
Manufactured in
PO Box 320, 1401 8th St SE, Orange City, IA, United States
Products
Protura Robotic Couch System Software, versions 1.6.1 (Part Number MT6XSM1.6.1), 1.7.0 (Part Number MT6XSM1.7.0), and 1.7.1 (Part Number MT6XSM1.7.1), CIVCO, Orange City, IA 51041
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1992-2016Don't want to check this manually?
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