Recall Z-0119-2014— Toshiba American Medical Systems Inc
Class II · Terminated
Class II FDA medical device recall by Toshiba American Medical Systems Inc, initiated 2013-08-05, terminated 2016-06-28. It names one FDA 510(k) clearance: K050380. Product: Xario Diagnostic Ultrasound System SSA-660A Used for routine diagnostic imaging. 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.
- Recalling firm
- Toshiba American Medical Systems Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-08-05
- Terminated
- 2016-06-28
- Firm location
- Tustin, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Xario Diagnostic Ultrasound System SSA-660A Used for routine diagnostic imaging
Reason for recall
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.