Toshiba American Medical Systems Inc recalls Toshiba Ultimax DREX-ULT80 X-ray generator

Recall date

May 19, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1398-2017

FDA classification

Class II

Brand / firm

Toshiba American Medical Systems Inc

Sold / distributed

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.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Toshiba Ultimax DREX-ULT80 X-ray generator