FDA-Device2013-11-06Class II
Aplio XG Diagnostic Ultrasound System SSA-790A Used for routine diagnostic imaging
Toshiba American Medical Systems Inc
Hazard
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
Sold states
Nationwide Distribution including and US Territory Puerto Rico
Affected count
430 (1352 total)
Manufactured in
2441 Michelle Dr, P.O. Box 2068, Tustin, CA, United States
Products
Aplio XG Diagnostic Ultrasound System SSA-790A Used for routine diagnostic imaging
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0122-2014Don't want to check this manually?
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