Xario Diagnostic Ultrasound System SSA660A 의 리콜

Recall

66059

Class 2

Z-0119-2014

2013-08-05

2013-10-30

Terminated

United States

2016-06-28

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=121394

The firm initiated this recall of certain toshiba diagnostic ultrasound systems because it has been found that under certain conditions, the temperature of the transducer head may increase in 2d+pw mode or 2d+cdi (power, adf) +pw mode. when the system is used under both conditions listed below, the temperature of the transducer head connected to the system may increase in temperature and possibly.

Toshiba sent an Urgent Medical Device Correction letter dated August 5, 2013. along with a Reply Form via USPS return receipt mail. The letter identified the product, the problem, and the action to be taken by the customer. Until the software is corrected customers were instructed to change the preset settings as described in the letter. Customers were asked to complete and return the attached form and fax it to the toll free number. The form also can be sent via email to raffairs@tams.com Customers with questions were instructed to call 800-421-1968 or contact their local Toshiba Representative at 800-521-1968. For questions regarding this recall call 714-730-5000.