FDA-Device2017-03-22Class II
Toshiba Kalare DREX-KL80 X-ray generator
Toshiba American Medical Systems Inc
Hazard
It was discovered that the generator of the system could possibly terminate the exposure prematurely during an examination
Sold states
USA ( nationwide ) Distribution to the states of : WA, OR, CA, OH, IL, CT, IA, KY, AL, LA, HI, PA, NJ, DE, MN, DC, NY, MI, SC, MD, TN, OK, WI, UT, ID, NV, TX, AL, IN, WV, KS, MO, CO, MT, MS, NC, GA, NH,UT, FL, AZ and ND.
Affected count
254
Manufactured in
PO Box 2068, 2441 Michelle Dr, Tustin, CA, United States
Products
Toshiba Kalare DREX-KL80 X-ray generator
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1397-2017Don't want to check this manually?
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