Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported September 6, 2017
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.
The issue was identified as a firmware problem with the generator.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Toshiba American Medical Systems Inc recalled Toshiba America Medical Systems Ultimax Digital Fluoroscopic X-Ray System Model: DREX-UI… - a moderate-severity action.
Toshiba America Medical Systems Ultimax Digital Fluoroscopic X-Ray System Model: DREX-UI… was recalled by Toshiba American Medical Systems Inc in September 6, 2017. Reason: The issue was identified as a firmware problem with the generator.. Check the official notice for the remedy. Verify recall #Z-3070-2017 with the FDA Devices before acting.
The recall
Toshiba American Medical Systems Inc issued this moderate-severity FDA Devices recall-The issue was identified as a firmware problem with the generator..
- Moderate
- severity level
- 18 units
- affected scope
- Class II
- classification
- September 6, 2017
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-3070-2017 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-3070-2017) was formally reported on September 6, 2017, with the manufacturer initiating the action on March 15, 2017. It is classified under Moderate severity (Class II), with a current status of Terminated. Toshiba American Medical Systems Inc is listed as the recalling firm, operating out of Tustin, CA. Federal records list the affected scope as 18.
The documented reason for this recall is: The issue was identified as a firmware problem with the generator. Distribution data in the federal record shows the product reached: US Distribution to the states of : LA, AR, IA, TX, IL, MN. MS, NJ, WV, SC, LA, WY, NC and CA.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,422 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
18
Related Recalls
6
0 from same agency
Product description
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.
Reason for recall
The issue was identified as a firmware problem with the generator.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-3070-2017 |
| Date reported | September 6, 2017 |
| Date initiated | March 15, 2017 |
| Recalling firm | Toshiba American Medical Systems Inc |
| Firm location | Tustin, CA |
| Affected scope | 18 |
| Distribution | US Distribution to the states of : LA, AR, IA, TX, IL, MN. MS, NJ, WV, SC, LA, WY, NC and CA. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-3070-2017) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Toshiba American Medical Systems Inc. Units affected: 18.
Why was this product recalled? ▼
The issue was identified as a firmware problem with the generator.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 6, 2017. Severity: Moderate. Recall number: Z-3070-2017.
Where was the recalled product distributed? ▼
Distribution: US Distribution to the states of : LA, AR, IA, TX, IL, MN. MS, NJ, WV, SC, LA, WY, NC and CA..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-3070-2017) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported September 6, 2017. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.