Z-0771-2007

Nemio XG, ultrasound system, SSA-590A with version 1.5 software, Toshiba American Medical Systems, Inc...

Name: Z-0771-2007 Nemio XG, ultrasound system, SSA-590A with version 1.5 software, Toshiba American Medical Systems, Inc...
Creator: Toshiba American Med Sys Inc
Published: 2006-12-19
License: https://open.fda.gov/license/

Canon Medical Systems USA, Inc. / initiated 2006-12-19 / Terminated

FDA source

Toshiba American Med Sys Inc began a recall of Nemio XG, ultrasound system, SSA-590A with version 1.5 software, Toshiba American Medical Systems, Inc., Tusin, CA on 2006-12-19. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0771-2007
Status: Terminated
Initiated: 2006-12-19
Posted: 2007-05-05
Terminated: 2012-02-15
Recalling firm: Canon Medical Systems USA, Inc.
Product: Nemio XG, ultrasound system, SSA-590A with version 1.5 software, Toshiba American Medical Systems, Inc., Tusin, CA.
Product code: ITX Transducer, Ultrasonic, Diagnostic
Reason for recall: 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.
FDA 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 to all users of the product and also with the Bio-medical Department at their facility.
Quantity in commerce: 37
Distribution: Nationwide Distribution including the states of CA, FL, GA, ID, MA, MN, NC, NY, PA, RI, TN, TX, WA, and WI.
Product codes and lots: 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;

Product code ITX

K061605Class IINemio Xg, Saa-580AToshiba America Medical Systems, In.C / cleared 2006-06-22

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)