Z-1397-2017 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- March 22, 2017
- Initiation Date
- May 19, 2016
- Termination Date
- June 14, 2018
- Voluntary/Mandated
- FDA Mandated
- Product Quantity
- 254
Product Description
Toshiba Kalare DREX-KL80 X-ray generator
Reason for Recall
It was discovered that the generator of the system could possibly terminate the exposure prematurely during an examination
Distribution Pattern
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.
Code Information
Model : KXO-80XD