FDA-Device2018-03-14Class II
INFX-8000H Fluoroscopic X-Ray Systems
Toshiba American Medical Systems Inc
Hazard
During an examination a device error occurred and the ceiling drive operation was disabled. It was found that the fastening bolts of the driving portion of the ceiling drive loosened cause the error.
Sold states
United States
Affected count
2 units
Manufactured in
PO Box 2068, 2441 Michelle Dr, Tustin, CA, United States
Products
INFX-8000H Fluoroscopic X-Ray Systems
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0845-2018Don't want to check this manually?
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