CLASS II Device recall · Reported 22 Mar 2017 · FDA Enforcement Report

Toshiba Ultimax Drex-ULT80 X-ray generator recalled

Toshiba American Medical Systems is recalling Toshiba Ultimax Drex-ULT80 X-ray generator, distributed nationwide in the US. The recall was initiated on 19 May 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel : KXO-80XM

Quantity recalled254

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1398-2017
FDA event ID: 76175
Recalling firm: Toshiba American Medical Systems, Tustin, CA
Classification: Class II
Status: Terminated
Recall initiated: 19 May 2016
FDA classified: 14 Mar 2017
Reported: 22 Mar 2017
Type: FDA Mandated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Imaging Equipment

Timeline

19 May 2016	Recall initiated by company
14 Mar 2017	Classified by FDA	+299 days
22 Mar 2017	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Product as listed by the FDA

Toshiba Ultimax DREX-ULT80 X-ray generator

Where it was 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.

Nationwide Alabama Arizona California Colorado Connecticut District of Columbia Delaware Florida Georgia Hawaii Iowa Idaho Illinois Indiana Kansas Kentucky Louisiana Maryland Michigan Minnesota

Questions about this recall

Why was it recalled?

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

Which lots are affected?

Model : KXO-80XM

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 76175

This product is part of a recall event; the main page for the event is Toshiba Kalare Drex-KL80 X-ray generator recalled.

Reported	Class	Recall	Company	Reason	Where
22 Mar 2017	CLASS II	Toshiba Kalare Drex-KL80 X-ray generator recalled	Toshiba American Medical Systems	Other	Nationwide

More recalls from Toshiba American Medical Systems

All 57

Reported	Class	Recall	Company	Reason	Where
4 Jul 2018Device	CLASS II	Diagnostic Ultrasound System, Aplio I-series recalled	Toshiba American Medical Systems	Device Malfunction	Nationwide
14 Mar 2018Device	CLASS II	Infx-8000V Fluoroscopic X-Ray Systems recalled	Toshiba American Medical Systems	Other	CA
14 Mar 2018Device	CLASS II	Infx-8000H Fluoroscopic X-Ray Systems recalled	Toshiba American Medical Systems	Other	CA
14 Mar 2018Device	CLASS II	Infx-8000F Fluoroscopic X-Ray Systems recalled	Toshiba American Medical Systems	Other	CA
14 Mar 2018Device	CLASS II	Infx-8000C Fluoroscopic X-Ray Systems recalled	Toshiba American Medical Systems	Other	CA

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