Aplio Artida V2.0 Ssh-880CV

• • Terminated Z-2897-2011 FDA Unclassified (pre-2012) ·initiated 1 Oct 2010

  Toshiba America Medical Systems, Inc. is initiating a field correction on the Aplio Artida Ultrasound Diagnostic System because the panel operation for the Aplio Artida may become disabled (i.e., system may hang up) when processing to display patient information (heart rate, time, VCP counter, ect.).

• • Terminated Z-1498-2011 FDA Unclassified (pre-2012) ·initiated 28 Sep 2010 ·on shared 510(k) K090158

  Toshiba America Medical Systems is initiating a field correction on the SSH-880CV Aplio Artida Diagnostic Ultrasound System due to software issues.

• • Terminated Z-2179-2011 FDA Unclassified (pre-2012) ·initiated 20 Apr 2010

  There is a possibility of the system shutting down owing to the power supply unit causing the protection function to activate thus turning off the system prematurely.

• • Terminated Z-2203-2011 FDA Unclassified (pre-2012) ·initiated 6 Jan 2010

  Toshiba America Medical Systems (TAMS) has become aware that the FLEX M software has reversed left and right annotation and post FLEX M measurement error, which may result in incorrect values.

• • Terminated Z-1955-2010 FDA Unclassified (pre-2012) ·initiated 16 Sep 2009 ·on shared 510(k) K090158

  Toshiba America Medical Systems (TAMS) is initiating a field correction on the SSH-880CV Aplio Artida System due to a problem related to a wrong measurement value display in using with DICOM viewer. When an image is transferred from this system in DICOM transfer and a measurement is performed on a Doppler image in the DICOM viewer, measured values such as VTI (Velocity Time Integral) and PI/RI

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K090158 ↗

FDA Product Code

IYN

Device Class

Class II

Regulation

21 CFR Part 892.1550

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

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