Z-2203-2011

Software for SSH-880CV Aplio Artida; System Diagnostic Ultrasound

Name: Z-2203-2011 Software for SSH-880CV Aplio Artida; System Diagnostic Ultrasound
Creator: Toshiba American Medical Systems Inc
Published: 2010-01-06
License: https://open.fda.gov/license/

Canon Medical Systems USA, Inc. / initiated 2010-01-06 / Terminated / root cause: software

FDA source

Toshiba American Medical Systems Inc began a recall of Software for SSH-880CV Aplio Artida; System Diagnostic Ultrasound on 2010-01-06. The reason FDA records is "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". 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-2203-2011
Status: Terminated
Initiated: 2010-01-06
Posted: 2011-05-19
Terminated: 2012-04-20
Recalling firm: Canon Medical Systems USA, Inc.
Product: Software for SSH-880CV Aplio Artida; System Diagnostic Ultrasound
Product code: IYN System, Imaging, Pulsed Doppler, Ultrasonic
Reason for recall: 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.
Root cause tag: software
FDA root cause: Software design
Action: The recall communication was initiated on 1/6/10 with Toshiba forwarding an Urgent: Medical Device Correction letter with attached Customer Notification Reply Form (via US Postal Service for US Customers) to all customers who purchased the FLEX-M mode on Aplio Artida Diagnostic Ultrasound System. The letter provides the customers with an explanation of the problem identified and an action to be taken. Customers were instructed to avoid performing M image measurement using images saved in FLEX-M mode until the corrective action is completed. If customers need to perform measurement for images saved in FLEX-M mode, they were instructed to use manual calibration. Customers were instructed to note that even though the corrective action is taken, the existing saved images (saved images before the corrective action is taken) are not modified. Therefore, when referring to the measured values on the images which are saved in FLEX-M mode before the corrective action is taken, customers were instructed to carefully handle the measurements results because they may be incorrect. Customers were instructed to complete the attached form and fax it to the toll free number at the top of the form. The form can also be sent via e-mail to [email protected]. If customers have any questions regarding the medical device correction letter, they can contact the Director of Regulatory Affairs at (800) 421-1968 or their local Toshiba representative.
Quantity in commerce: 28
Distribution: Nationwide Distribution -- Including states of IA, MT, PA, CA, OR, GA, LA, OH, TX, MA, OH, WI, and Puerto Rico.
Product codes and lots: W1A0822031-33, W1A0822048-49, W1A0832056, W1A0842069-70, W1B0852071-80, W1B0862087-8, W1C0872103-08, W1C0882119-24, W1F0972204-06, W1F0972218-20, W1F0992260-62, W1F0992268, and W1F0992270-73.

Product code IYN

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)