CLASS II Device recall · Reported 19 Jul 2017 · FDA Enforcement Report

Xario 200 Tus-X200 diagnostic ultrasound system recalled

Toshiba American Medical Systems is recalling Xario 200 Tus-X200 diagnostic ultrasound system, distributed nationwide in the US. The recall was initiated on 1 May 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSerial Number W5B1712472

Quantity recalled1 unit

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2709-2017
FDA event ID: 77599
Recalling firm: Toshiba American Medical Systems, Tustin, CA
Classification: Class II
Status: Terminated
Recall initiated: 1 May 2017
FDA classified: 10 Jul 2017
Reported: 19 Jul 2017
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Imaging Equipment

Timeline

1 May 2017	Recall initiated by company
10 Jul 2017	Classified by FDA	+70 days
19 Jul 2017	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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.

Product as listed by the FDA

XARIO 200 TUS-X200 diagnostic ultrasound system

Where it was distributed

Nationwide Distribution

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

Serial Number W5B1712472

Where was it sold?

Nationwide Distribution

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

4 other products · FDA event 77599

Reported	Class	Recall	Company	Reason	Where
19 Jul 2017	CLASS II	Aplio 500 Tus-A500 diagnostic ultrasound system recalled	Toshiba American Medical Systems	Other	Nationwide
19 Jul 2017	CLASS II	Xario 100 Tus-X100 diagnostic ultrasound system recalled	Toshiba American Medical Systems	Other	Nationwide
19 Jul 2017	CLASS II	Aplio i-series: a) Aplio i700 Tus AI700 b) Aplio i800 Tus recalled	Toshiba American Medical Systems	Other	Nationwide
19 Jul 2017	CLASS II	Aplio 300 Tus-A300 diagnostic ultrasound system recalled	Toshiba American Medical Systems	Other	Nationwide

More recalls from Toshiba American Medical Systems

All 57

Reported	Class	Recall	Company	Reason	Where
4 Jul 2018Device	CLASS II	Diagnostic Ultrasound System, Aplio I-series recalled	Toshiba American Medical Systems	Device Malfunction	Nationwide
14 Mar 2018Device	CLASS II	Infx-8000V Fluoroscopic X-Ray Systems recalled	Toshiba American Medical Systems	Other	CA
14 Mar 2018Device	CLASS II	Infx-8000H Fluoroscopic X-Ray Systems recalled	Toshiba American Medical Systems	Other	CA
14 Mar 2018Device	CLASS II	Infx-8000F Fluoroscopic X-Ray Systems recalled	Toshiba American Medical Systems	Other	CA
14 Mar 2018Device	CLASS II	Infx-8000C Fluoroscopic X-Ray Systems recalled	Toshiba American Medical Systems	Other	CA

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