Z-1955-2010

SSH-880CV Aplio Artida System

Name: Z-1955-2010 SSH-880CV Aplio Artida System
Creator: Toshiba American Medical Systems Inc
Published: 2009-09-16
License: https://open.fda.gov/license/

Canon Medical Systems USA, Inc. / initiated 2009-09-16 / Terminated / root cause: software

FDA source

Toshiba American Medical Systems Inc began a recall of SSH-880CV Aplio Artida System on 2009-09-16. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1955-2010
Status: Terminated
Initiated: 2009-09-16
Posted: 2010-07-06
Terminated: 2012-03-21
Recalling firm: Canon Medical Systems USA, Inc.
Product: SSH-880CV Aplio Artida System
Product code: IYO System, Imaging, Pulsed Echo, Ultrasonic
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
Root cause tag: software
FDA root cause: Software design
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.
Quantity in commerce: 22
Distribution: Nationwide ((CA, GA, IA, LA, MA, MD, MN, MT, PA, PR, OH, OR, TN).
Product codes and lots: 2031, 2032, 2033, 2048, 2049, 2056, 2069, 2070, 2071, 2072, 2073, 2074, 2075, 2076, 2077, 2078, 2079, 2080, 2087, 2088, 2103, 2104, 2105, 2106, 2707, 2108, 2119, 2120, 2123, 2124, 2204, 2205, 2206

Product code IYO

K090158Class IIAplio Artida V2.0 Ssh-880CvToshiba America Medical Systems, In.C / cleared 2009-02-06

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)