FDA-Device2014-06-11Class II
Toshiba Infinix X-Ray Interventional System INFX-8000V/UU. An X-Ray system that is capable of radiographic and fluoroscopic studies used in an interventional setting.
Toshiba American Medical Systems Inc
Hazard
Although the Flat Panel Detector (FPD) touch sensor is activated during use, the error message is displayed and the audible signal continues sounding during the table movement of longitudinal tilt, the movement of longitudinal tilt does not stop.
Sold states
Nationwide Distribution including CA and IN
Affected count
2
Manufactured in
2441 Michelle Dr, P.O. Box 2068, Tustin, CA, United States
Products
Toshiba Infinix X-Ray Interventional System INFX-8000V/UU. An X-Ray system that is capable of radiographic and fluoroscopic studies used in an interventional setting.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1714-2014Don't want to check this manually?
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