Z-3070-2017Class II

Toshiba America Medical Systems Ultimax Digital Fluoroscopic X-Ray System Model: DREX-UI80 Ultimax is...

Name: Z-3070-2017 Toshiba America Medical Systems Ultimax Digital Fluoroscopic X-Ray System Model: DREX-UI80 Ultimax is...
Creator: Toshiba American Medical Systems Inc
Published: 2017-03-15
License: https://open.fda.gov/license/

Canon Medical Systems USA, Inc. / initiated 2017-03-15 / Terminated / root cause: software

FDA source

Toshiba American Medical Systems Inc began a recall of Toshiba America Medical Systems Ultimax Digital Fluoroscopic X-Ray System Model: DREX-UI80 Ultimax is intended for gastrointestinal studies, vascular studies... on 2017-03-15. FDA classified it as Class II and gives the reason as "The issue was identified as a firmware problem with the generator". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-3070-2017
Classification: Class II
Status: Terminated
Initiated: 2017-03-15
Posted: 2017-08-30
Terminated: 2020-09-25
Recalling firm: Canon Medical Systems USA, Inc.
Product: 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.
Product code: OWB Interventional Fluoroscopic X-Ray System
Reason for recall: The issue was identified as a firmware problem with the generator.
Root cause tag: software
FDA root cause: Software design
Action: Toshiba America Medical Systems ( TAMS) will bring the defect into Compliance: 1.You will issue a Customer Notification Letter to make customers aware of the hazards, what measures will be taken to remedy the defect at no cost to the user, and how to safely use the equipment before corrections can be made. 2.You will install modified firmware on the systems to correct the defect and prevent recurrence. 3.You will provide progress reports on the effectiveness of the plan. For further questions, please call (714) 730-5000.
Quantity in commerce: 18
Distribution: US Distribution to the states of : LA, AR, IA, TX, IL, MN. MS, NJ, WV, SC, LA, WY, NC and CA.
Product codes and lots: Ser. No. U1A1692606

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3070-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3070-2017	Class II	Terminated	FDA Mandated	2017-09-06	2017-08-30

Product code OWB

K170832Class IIUltimax-i, DREX-UI80 V1.60Toshibamedical Systems Corporation / cleared 2017-07-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)