Toshiba American Med Sys Inc Nemio XG, ultrasound system, SSA-590A with version 1.5 software, Toshiba American Medical Systems, Inc., Tusin, CA. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Nemio XG, ultrasound system, SSA-590A with version 1.5 software, Toshiba American Medical Systems, Inc., Tusin, CA.
Brand
Toshiba American Med Sys Inc
Lot Codes / Batch Numbers
Serial #: A1A0642100, A1A0642102, A1B0662183, A1B0662184, A1B0662256, A1B0662257, A1B0662258, A1B0662327, A1B0662328, A1B0662330, A1B0662331, A3A0652115, A3B0662284, A3B0662285, A3B0662286, A3B0662287, A3B0662288, A3B0662289, A3B0662290, A3B0662291, A3B0662292, A3B0662293, A3B0662371, A3B0662372, A3B0662373, A3B0662374, A3B0662375, A3B0662376, A3B0662377, A3B0662378, A3B0662379, A3B0662380, A3B0672415, A3B0672416, A3B0672417, A3B0672418, A3B0672419
Products Sold
Serial #: A1A0642100; A1A0642102; A1B0662183; A1B0662184; A1B0662256; A1B0662257; A1B0662258; A1B0662327; A1B0662328; A1B0662330; A1B0662331; A3A0652115; A3B0662284; A3B0662285; A3B0662286; A3B0662287; A3B0662288; A3B0662289; A3B0662290; A3B0662291; A3B0662292; A3B0662293; A3B0662371; A3B0662372; A3B0662373; A3B0662374; A3B0662375; A3B0662376; A3B0662377; A3B0662378; A3B0662379; A3B0662380; A3B0672415; A3B0672416; A3B0672417; A3B0672418; A3B0672419;
Toshiba American Med Sys Inc is recalling Nemio XG, ultrasound system, SSA-590A with version 1.5 software, Toshiba American Medical Systems, I due to Transducer Surface Temperature : It was found during testing that when using the system in the 2DCDI + PW mode, with the Scale Graph function active, . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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 to all users of the product and also with the Bio-medical Department at their facility.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026