Device product
Xario Diagnostic Ultrasound System SSA-660A Used for routine diagnostic imaging
Z-0119-2014
Product summary
- Event
- Event 66059
- Status
- Terminated
- Classification
- Class II
- Quantity
- 17 (1352 Total)
- Official record key
device-enforcement:Z-0119-2014
Official wording
Reason: 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
Code information: Lot Numbers not utilized. Serial Numbers: LGA0792628 LGA0792564 LGA0792565 LGA0792531 LGA0792540 LGA0792541 LGA0792617 LGA0792554 LGA0792626 LGA0792627 LGA0792552 LGA0792616 LGA0792563 LGA0792553 LGA0792615 LGA0792551 LGA0792613
Distribution pattern: Nationwide Distribution including and US Territory Puerto Rico
Derived failure modes
-
Unknown
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