FDAClass IIMarch 22, 2017

Toshiba Ultimax DREX-ULT80 X-ray generator recall

Toshiba Ultimax DREX-ULT80 X-ray generator

Why was Toshiba Ultimax DREX-ULT80 X-ray generator recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Model : KXO-80XM

Product
Toshiba Ultimax DREX-ULT80 X-ray generator
Recalling firm
Toshiba American Medical Systems Inc
Quantity
254
Distribution
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.
Recall date
March 22, 2017
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls