FDA-Device2013-07-17Class II
TOSHIBA Kalare Diagnostic X-Ray System K110785
Toshiba American Medical Systems Inc
Hazard
Firm initiated recall because when radiographic conditions with the small focus are set and the radiography ready switch is held down, the large focus is also heated after a few seconds or more. This occurs when the Automatic Exposure Function (AEC) function is used. As a result, a radiographic tube current exceeding the set value flows and a brighter image than expected is acquired.
Sold states
US Nationwide Distribution
Affected count
153 units
Manufactured in
2441 Michelle Dr, P.O. Box 2068, Tustin, CA, United States
Products
TOSHIBA Kalare Diagnostic X-Ray System K110785
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1598-2013Don't want to check this manually?
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