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Recall Observatory FDA recall evidence

Device product

APLIO i-series: a) APLIO i700 TUS AI700 b) APLIO i800 TUS AI800 diagnostic ultrasound system

Z-2712-2017

May 01, 2017

Class II

Product summary

Firm
Toshiba American Medical Systems Inc
Event
Event 77599
Status
Terminated
Classification
Class II
Quantity
28 units
Official record key
device-enforcement:Z-2712-2017

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: a) JHA16X2002, HAB16Z2001, HAB16Z2002, HAB16Z2003, HAB16Z2004, HAB16Z2005, HAB1732007, HAB1732009 b) HAB16Z2002, HAB16Z2003, HAB1712006, HAB1712007, HAB1712008, HAB1712009, HAB1712010, HAB1722011, HAB1722012, HAB1732013, HAB1732014, HAB1732015, HAB1732016, HAB1732017, HAB1732018, HAB1732020, HAB1732021, HAB1732025, HAB1732027, HAB1732030

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.