SSH-880CV Aplio Artida; System, Diagnostic Ultrasound
FDA Recall Z-1498-2011 · Posted 2011-03-03
Recalling FirmToshiba American Medical Systems Inc
Recall StatusTerminated
Product CodeIYO
Date Initiated2010-09-28
Date Terminated2012-05-02
Product Quantity40 units
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.
Firm 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.
Root Cause
Software design
Distribution Pattern
Nationwide Distribution to CA, GA, IA, IL KY, LA, MA, MN, MT, OH, OR, PA, TX, WI, and Puerto Rico.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.