Aplio XG model SSA-790A Aplio XG (SSA-790A) is a premium-class diagnostic ultrasound system incorporating state-of-the-art technologies. It is provided with the highest level of image quality and operability (reflecting the XG (next Generation) in its name), and can be used with ease for research as well as for routine clinical studies.
FDA Recall Z-2981-2011 · Posted 2011-08-10
Recalling FirmToshiba American Medical Systems Inc
Recall StatusTerminated
Product CodeIYO
Date Initiated2010-06-02
Date Terminated2012-04-20
Product Quantity78
Reason for Recall
Toshiba America Medical Systems Inc (TAMS) is initiating a field correction on the the Aplio XG model SSA-790A because it did not meet the requirement of clause 15b, IEC60601-1 which requires that the residual voltage shall not exceed 60V after 1 second from taking off the AC plug.
Firm Action
Toshiba America Medical Systems (TAMS) sent an "URGENT:MEDICAL DEVICE CORRECTION' letter dated June 2, 2010 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers.
Customers were instructed to be careful not to touch the contacts or prongs on the AC plug within two seconds after unplugging the system from a wall socket. This precaution is to be adhered to until a Toshiba Service Representative replaces the power supply. Customers are to complete and return a Customer Reply Form and fax to 877-349-3054.
Customers with questions regarding the notification should contact the Director of Regulatory Affairs at (800) 421-1968 or call their local Toshiba Representative at (800) 521-1968.
Root Cause
Device Design
Distribution Pattern
Nationwide Distribution
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.