Z-1498-2011

SSH-880CV Aplio Artida; System, Diagnostic Ultrasound

Name: Z-1498-2011 SSH-880CV Aplio Artida; System, Diagnostic Ultrasound
Creator: Toshiba American Medical Systems Inc
Published: 2010-09-28
License: https://open.fda.gov/license/

Canon Medical Systems USA, Inc. / initiated 2010-09-28 / Terminated / root cause: software

FDA source

Toshiba American Medical Systems Inc began a recall of SSH-880CV Aplio Artida; System, Diagnostic Ultrasound on 2010-09-28. The reason FDA records is "Toshiba America Medical Systems is initiating a field correction on the SSH-880CV Aplio Artida Diagnostic Ultrasound System due to software issues". 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-1498-2011
Status: Terminated
Initiated: 2010-09-28
Posted: 2011-03-03
Terminated: 2012-05-02
Recalling firm: Canon Medical Systems USA, Inc.
Product: SSH-880CV Aplio Artida; System, Diagnostic Ultrasound
Product code: IYO System, Imaging, Pulsed Echo, Ultrasonic
Reason for recall: Toshiba America Medical Systems is initiating a field correction on the SSH-880CV Aplio Artida Diagnostic Ultrasound System due to software issues.
Root cause tag: software
FDA root cause: Software design
Action: Toshiba America Medical Systems (TAMS) sent an URGENT MEDICAL DEVICE CORRECTION letter to consignees via USPS return receipt mail. The letter contained a return reply form that is to be faxed to TAMS at 877-349-3054 as proof of notification. Customers were instructed to share the information with all users and reviewing radiologists as well as clinical engineering or biomedical group at their facility. For questions regarding this recall call 800-421-1968 or 800-521-1968.
Quantity in commerce: 40 units
Distribution: Nationwide Distribution to CA, GA, IA, IL KY, LA, MA, MN, MT, OH, OR, PA, TX, WI, and Puerto Rico.
Product codes and lots: Serial Numbers (last 4): 2031, 2033, 2069, 2070, 2072, 2073, 2074, 2076, 2077, 2079, 2087, 2088, 2103, 2105, 2107, 2120, 2205, 2206, 2218, 2219, 2220, 2260, 2262, 2268, 2270, 2271, 2272, 2273, 2280, 2281, 2311, 2313, 2334, 2335, 2340, 2341, 2347, 2348, 2360, 2361, 2389, 2390, 2405, 2032, 2048, 2049, 2056, 2071, 2075, 2078, 2080, 2104, 2106, 2108, 2119, 2123, 2124, 2204, 2261, 2282, 2296, 2297, 2312, 2342, 2389, 2390, 2405

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)