Recall Z-2981-2011 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic
Toshiba American Medical Systems Inc
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.
| Date | Aug 10, 2011 (initiated Jun 2, 2010) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Device Design |
| 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 regard |
| Quantity | 78 |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K091295 | APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM MODEL SSA-790A VERSION 4.0 Toshiba America Medical Systems, In.C, May 15, 2009 |