Recall Z-0771-2007 ยท ITX Transducer, Ultrasonic, Diagnostic
Toshiba American Med Sys Inc
Nemio XG, ultrasound system, SSA-590A with version 1.5 software, Toshiba American Medical Systems, Inc., Tusin, CA.
| Date | May 5, 2007 (initiated Dec 19, 2006) |
| Status | Terminated |
| Reason | Transducer Surface Temperature : It was found during testing that when using the system in the 2DCDI + PW mode, with the Scale Graph function active, that the transducer surface temperature could exceed the 27 degrees Celsius limit as specified in the IEC safety standard. |
| Root cause | Other |
| Action | Notification letters were sent to customers on December 19, 2206. Customers were instructed to avoid using Scale Graph function with live images, and instructed to call up the Scale Graph after images are frozen. Customers were informed that a Toshiba Customer Service Engineer will contact them to schedule a software upgrade when software becomes available. 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. Customers were also instructed to distribute this information |
| Quantity | 37 |
| Distribution | Nationwide Distribution including the states of CA, FL, GA, ID, MA, MN, NC, NY, PA, RI, TN, TX, WA, and WI. |
| 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 |