Xario Diagnostic Ultrasound System SSA-660A Used for routine diagnostic imaging
This recall has been terminated (originally issued October 30, 2013).
- Recall Initiated
- August 5, 2013
- Posted
- October 30, 2013
- Terminated
- June 28, 2016
- Recall Number
- Z-0119-2014
- Quantity
- 17 (1352 Total)
- Firm Location
- Tustin, CA
- Official Source
- View on FDA website ↗
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
Distribution
Nationwide Distribution including and US Territory Puerto Rico
Lot / Code Info
Lot Numbers not utilized. Serial Numbers: LGA0792628 LGA0792564 LGA0792565 LGA0792531 LGA0792540 LGA0792541 LGA0792617 LGA0792554 LGA0792626 LGA0792627 LGA0792552 LGA0792616 LGA0792563 LGA0792553 LGA0792615 LGA0792551 LGA0792613
Root Cause
Device Design
Action Taken
Toshiba sent an Urgent Medical Device Correction letter dated August 5, 2013. along with a Reply Form via USPS return receipt mail. The letter identified the product, the problem, and the action to be taken by the customer. Until the software is corrected customers were instructed to change the preset settings as described in the letter. Customers were asked to complete and return the attached form and fax it to the toll free number. The form also can be sent via email to raffairs@tams.com Customers with questions were instructed to call 800-421-1968 or contact their local Toshiba Representative at 800-521-1968. For questions regarding this recall call 714-730-5000.