The Recall Desk
HighFDA (Devices)·Z-2712-2017·Announced 2017-07-19

Toshiba APLIO i-series Ultrasound Systems Recalled for Incorrect Velocity Readings

Toshiba is recalling 28 APLIO i-series diagnostic ultrasound systems because they may display incorrect velocity values when using the Continuous Trace method.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk of harm (incorrect diagnostic data) where injury has not yet been reported, fitting the High severity criteria.

Plain-English summary

Toshiba American Medical Systems Inc is recalling 28 units of the APLIO i-series diagnostic ultrasound systems, specifically the APLIO i700 (TUS AI700) and APLIO i800 (TUS AI800) models. The recall affects units distributed nationwide.

The recall is due to a software issue where the systems may display incorrect values in the ultrasound workstations when the Continuous Trace method is used for velocity trace measurement on Spectral Doppler. This error could lead to inaccurate diagnostic data.

Healthcare facilities and users of these specific serial numbers should contact Toshiba American Medical Systems Inc for further instructions on how to resolve the issue. The affected serial numbers are listed in the official recall documentation.

The recalled product

Product
APLIO i-series: a) APLIO i700 TUS AI700 b) APLIO i800 TUS AI800 diagnostic ultrasound system
Manufacturer
Toshiba American Medical Systems Inc
Category
Medical Device — Diagnostic Ultrasound
Hazard
Affected units
28

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • Serial Numbers: a) JHA16X2002
  • HAB16Z2001
  • HAB16Z2002
  • HAB16Z2003
  • HAB16Z2004
  • HAB16Z2005
  • HAB1732007
  • HAB1732009 b) HAB16Z2002
  • HAB1712006
  • HAB1712007
  • HAB1712008
  • HAB1712009
  • HAB1712010
  • HAB1722011
  • HAB1722012
  • HAB1732013
  • HAB1732014
  • HAB1732015
  • HAB1732016
  • HAB1732017

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 5 recalled by Toshiba American Medical Systems Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 5 products in this recall →

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Same manufacturer · Toshiba American Medical Systems Inc

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Same hazard · incorrect data

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