Reported Jul 19, 2017 · Terminated

XARIO 100 TUS-X100 diagnostic ultrasound system

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 · PO Box 2068 · Tustin, CA · 92780-7047

Is this the product you have?

  • XARIO 100 TUS-X100 diagnostic ultrasound system
Lot codes and dates
  • Serial Numbers
    • W5B16Z2555
    • W5B1712642
    • MXA1723100
    • MXA1723098
    • MXA1723101
    • MXA1723099
    • MXA1723097
Amount recalled
7 units

This recall covers 5 products

The agency filed one notice per product. You are reading one of them; the other 4 are below.

Where it was sold

  • Nationwide

Why it was recalled

When Continuous Trace method is used as the tracing method on Spectral Doppler in velocity trace measurement, an incorrect value may be displayed in the ultrasound systems and in the ultrasound workstations listed below.

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

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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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 11, 2023 · Data as of Sep 19, 6:06 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.