The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-3070-2017·Announced 2017-09-06

Toshiba Ultimax Digital Fluoroscopic X-Ray System Recalled for Firmware Issue

Toshiba is recalling 18 Ultimax Digital Fluoroscopic X-Ray Systems due to a firmware problem with the generator.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II. Per the rubric, FDA Class II recalls without explicit reports of hospitalization or significant injury are assigned a score of 3 (High), representing a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Toshiba American Medical Systems Inc is recalling 18 units of the Ultimax Digital Fluoroscopic X-Ray System, Model DREX-UI80. The recall is due to a firmware problem with the generator.

The affected units were distributed in the United States to the states of Louisiana, Arkansas, Iowa, Texas, Illinois, Minnesota, Mississippi, New Jersey, West Virginia, South Carolina, Wyoming, North Carolina, and California. The specific serial number for the affected unit is U1A1692606.

This is a Class II recall. The FDA classifies Class II recalls as situations where use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

The recalled product

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…
Manufacturer
Toshiba American Medical Systems Inc
Category
Medical Device — Imaging Equipment
Hazard
Affected units
18

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Ser. No. U1A1692606

Distribution

Distributed in 13 states:

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