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Toshiba American Medical Systems Inc recalls Aplio XG Diagnostic Ultrasound System SSA-790A Used for routine diagnostic imaging
Recalled November 6, 2013 · FDA recall Z-0122-2014 · Toshiba American Medical Systems
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 · FDA Class II
Units
430 (1352 total)
Sold at
Nationwide Distribution including and US Territory Puerto Rico
Description
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
Product
Aplio XG Diagnostic Ultrasound System SSA-790A Used for routine diagnostic imaging
Manufacturer(s)
Toshiba American Medical Systems Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →