Reported Jun 11, 2014 · Terminated

Toshiba Infinix X-Ray Interventional System INFX-8000V/UU. An X-Ray system that is capable of radiographic and…

Toshiba American Medical Systems Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Toshiba American Medical Systems Inc · 2441 Michelle Dr · Tustin, CA · 92780-7047

Is this the product you have?

  • Toshiba Infinix X-Ray Interventional System INFX-8000V/UU. An X-Ray system that is capable of radiographic and fluoroscopic studies used in an interventional setting.
Lot codes and dates
  • Serial Numbers
    • ULD1412014
    • UUC13Z2011
    • A4A113Z2001
Amount recalled
2

Where it was sold

Why it was recalled

Although the Flat Panel Detector (FPD) touch sensor is activated during use, the error message is displayed and the audible signal continues sounding during the table movement of longitudinal tilt, the movement of longitudinal tilt does not stop.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Oct 2, 2014 · Data as of Sep 19, 5:31 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.