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Terminated

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

FDA Recall Z-0771-2007 · Posted 2007-05-05

Recalling FirmToshiba American Med Sys Inc
Recall StatusTerminated
Product CodeITX
Date Initiated2006-12-19
Date Terminated2012-02-15
Product Quantity37

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.

Firm 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.

Root Cause

Other

Distribution Pattern

Nationwide Distribution including the states of CA, FL, GA, ID, MA, MN, NC, NY, PA, RI, TN, TX, WA, and WI.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K061605NEMIO XG, SAA-580AToshiba America Medical Systems, In.C · 2006-06-22

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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