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Terminated

SSH-880CV Aplio Artida System

FDA Recall Z-1955-2010 · Posted 2010-07-06

Recalling FirmToshiba American Medical Systems Inc
Recall StatusTerminated
Product CodeIYO
Date Initiated2009-09-16
Date Terminated2012-03-21
Product Quantity22

Reason for Recall

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

Firm Action

The software will be replaced. To accomplish this, Toshiba America Medical Systems (TAMS) will notify consignees via USPS return receipt mail. The letter contains a return reply form that is to be faxed to TAMS for retention. For questions or concerns, please contact your Toshiba representative or the firm at (714) 730-5000.

Root Cause

Software design

Distribution Pattern

Nationwide ((CA, GA, IA, LA, MA, MD, MN, MT, PA, PR, OH, OR, TN).

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K090158APLIO ARTIDA V2.0 SSH-880CVToshiba America Medical Systems, In.C · 2009-02-06

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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