CLASS II Device recall · Reported 6 Sep 2017 · FDA Enforcement Report

Toshiba America Medical Systems Ultimax Digital recalled

Toshiba American Medical Systems is recalling Toshiba America Medical Systems Ultimax Digital Fluoroscopic X-Ray System, distributed in 13 states. The recall was initiated on 15 Mar 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSer. No. U1A1692606

Quantity recalled18

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-3070-2017
FDA event ID: 77679
Recalling firm: Toshiba American Medical Systems, Tustin, CA
Classification: Class II
Status: Terminated
Recall initiated: 15 Mar 2017
FDA classified: 30 Aug 2017
Reported: 6 Sep 2017
Type: FDA Mandated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Heart & Vascular Devices

Timeline

15 Mar 2017	Recall initiated by company
30 Aug 2017	Classified by FDA	+168 days
6 Sep 2017	Published in enforcement report	+7 days

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

Reason for recall

The issue was identified as a firmware problem with the generator.

Product as listed by the FDA

Toshiba America Medical Systems Ultimax Digital Fluoroscopic X-Ray System Model: DREX-UI80 Ultimax is intended for gastrointestinal studies, vascular studies, general radiography, and fluoroscopy. The system has medical applications ranging from but not limited to: contrast-enhanced studies, support of endoscopic studies, nonvascular contrast-enhanced studies, nonvascular IVR, vascular contrast-enhanced studies support of vascular NR, and general radiography.

Where it was distributed

US Distribution to the states of : LA, AR, IA, TX, IL, MN. MS, NJ, WV, SC, LA, WY, NC and CA.

Arkansas California Iowa Illinois Louisiana Minnesota Mississippi North Carolina New Jersey South Carolina Texas West Virginia Wyoming

Questions about this recall

Why was it recalled?

The issue was identified as a firmware problem with the generator.

Which lots are affected?

Ser. No. U1A1692606

Where was it sold?

US Distribution to the states of : LA, AR, IA, TX, IL, MN. MS, NJ, WV, SC, LA, WY, NC and CA.

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.

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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