Toshiba American Medical Systems Inc: Medical Device Recall in 2017 - (Recall #: Z-1397-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

Toshiba Kalare DREX-KL80 X-ray generator

Product Classification:

Class II

Date Initiated: May 19, 2016

Date Posted: March 22, 2017

Recall Number: Z-1397-2017

Event ID: 76175

Reason for Recall:

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

Status: Terminated

Product Quantity: 254

Code Information:

Model : KXO-80XD

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.

Voluntary or Mandated:

FDA Mandated