Skip to content
Recall Observatory FDA recall evidence

Device product

Toshiba Ultimax DREX-ULT80 X-ray generator

Z-1398-2017

May 19, 2016

Class II

Product summary

Firm
Toshiba American Medical Systems Inc
Event
Event 76175
Status
Terminated
Classification
Class II
Quantity
254
Official record key
device-enforcement:Z-1398-2017

Official wording

Reason: It was discovered that the generator of the system could possibly terminate the exposure prematurely during an examination

Code information: Model : KXO-80XM

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    It was discovered that the generator of the system could possibly terminate the exposure prematurely during an examination