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Recall Observatory FDA recall evidence

Device product

XARIO 100 TUS-X100 diagnostic ultrasound system

Z-2708-2017

May 01, 2017

Class II

Product summary

Firm
Toshiba American Medical Systems Inc
Event
Event 77599
Status
Terminated
Classification
Class II
Quantity
7 units
Official record key
device-enforcement:Z-2708-2017

Official wording

Reason: 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.

Code information: Serial Numbers: W5B16Z2555, W5B1712642, MXA1723100, MXA1723098, MXA1723101, MXA1723099, MXA1723097

Distribution pattern: Nationwide Distribution

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.