FDA (Devices) recall action 66059
The FDA (Devices) publishes a recall like this one as 4 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 4 pages.
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
The agency’s own wording, quoted from the enforcement report.
Toshiba is recalling 477 Xario XG Diagnostic Ultrasound Systems because the transducer head may overheat during specific imaging modes.
Toshiba is recalling 427 Aplio MX Diagnostic Ultrasound Systems because the transducer head may overheat during specific imaging modes.
Toshiba is recalling 17 diagnostic ultrasound systems because the transducer head may overheat under specific operating modes, posing a burn risk to patients.
Toshiba is recalling 430 diagnostic ultrasound systems because the transducer head may overheat under specific operating conditions.