Recall Z-0254-2008 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
Toshiba American Med Sys Inc
NEMIO XG Ultrasound System, Model SSA-580A , Software versions: VI .5.0, Vl .5.000A, VI .5.000B, V2.0.0,Toshiba America Medical Systems, Inc., Tustin, CA.
| Date | Nov 17, 2007 (initiated Aug 29, 2007) |
| Status | Terminated |
| Reason | Multiple problems including : (1) The surface temperature of the transducer tip can rise and exceed the limit set by the international standard. (2) Incorrect display of the TI indices on the display monitor. The displayed value is greater or smaller than the true TI value, and (3) Manuals contain incorrect values for MI/TI values. |
| Root cause | Software design |
| Action | Urgent Medical Device Notification letters were sent to customers on August 29, 2007. Customers were notified of the several issues related to the Nemio SSA-550A and Nemio SSA-580A recall and asked to share this information with all users of the device. Customers were informed that Toshiba is preparing software and corrected manuals for distribution to address these issues. If customers have any questions they were instructed to contact their Toshiba Customer Service Engineer or call (800) 421-1968 and ask for the Regulatory Affairs Department. |
| Quantity | 128 units |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K061605 | NEMIO XG, SAA-580A Toshiba America Medical Systems, In.C, Jun 22, 2006 |