Z-2897-2011

Aplio Artida Ultrasound Diagnostic System SSH-880CV. Toshiba American Medical Systems, Inc. A diagnostic...

Name: Z-2897-2011 Aplio Artida Ultrasound Diagnostic System SSH-880CV. Toshiba American Medical Systems, Inc. A diagnostic...
Creator: Toshiba American Medical Systems Inc
Published: 2010-10-01
License: https://open.fda.gov/license/

Canon Medical Systems USA, Inc. / initiated 2010-10-01 / Terminated / root cause: software

FDA source

Toshiba American Medical Systems Inc began a recall of Aplio Artida Ultrasound Diagnostic System SSH-880CV. Toshiba American Medical Systems, Inc. A diagnostic ultrasound system on 2010-10-01. The reason FDA records is "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)...". 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-2897-2011
Status: Terminated
Initiated: 2010-10-01
Posted: 2011-07-29
Terminated: 2012-04-20
Recalling firm: Canon Medical Systems USA, Inc.
Product: Aplio Artida Ultrasound Diagnostic System SSH-880CV. Toshiba American Medical Systems, Inc. A diagnostic ultrasound system.
Product code: IYN System, Imaging, Pulsed Doppler, Ultrasonic
Reason for recall: 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.).
Root cause tag: software
FDA root cause: Software design
Action: Toshiba America Medical Systems, Inc. sent out an "Urgent Medical Device Correction" dated December 21, 2010 to all affected customers. The letter provides the customers with an explanation of the problem identified and an action to be taken. Customers were notified that Toshiba will issue a field modification to correct the software, and if the problem occurs, they were instructed to shutdown the system holding down the power supply button for 5 seconds for 5 seconds and then restart the system. A form to send back to Toshiba is included. For questions on this recall call (800) 421-1968 or contact your local Toshiba Representative at (800) 521-1968.
Quantity in commerce: 46 units
Distribution: Worldwide Distribution: (USA) Nationwide distribution including the states of MD, OH, PA, NY, MA, GA, AL, TX, IL, WI, IA, MN, KY, MT, OR, LA, and CA; and the country of Puerto Rico.
Product codes and lots: Last 4 of serial number: 2342, 2480, 2073, 2120, 2219, 2270, 2271, 2268, 2389, 2390, 2297, 2206, 2033, 2107, 2087, 2311, 2281, 2273, 2340, 2341, 2313, 2272, 2070, 2335, 2347, 2348, 2360, 2361, 2048, 2280, 2031, 2088, 2076, 2077, 2105, 2334, 2220, 2260, 2205, 2072, 2074, 2079, 2218, 2103, 2262, 2069, 2106, 2119, 2124, 2204, 2405, 2104, 2032, 2075, 2080, 2108, 2261, 2312, 2078, 2071, 2123, 2296, 2282, 2049, and 2056.

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)