Toshiba American Medical Systems Inc: Medical Device Recall in 2017 - (Recall #: Z-3070-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: March 15, 2017

Date Posted: September 6, 2017

Recall Number: Z-3070-2017

Event ID: 77679

Reason for Recall:

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

Status: Terminated

Product Quantity: 18

Code Information:

Ser. No. U1A1692606

Distribution Pattern:

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

Voluntary or Mandated:

FDA Mandated