Reported Jul 19, 2017 · Terminated
XARIO 200 TUS-X200 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 200 TUS-X200 diagnostic ultrasound system
- Lot codes and dates
- Serial Number W5B1712472
- Amount recalled
- 1 unit
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.
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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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