Recall Z-0121-2014 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
Toshiba American Medical Systems Inc
Aplio MX Diagnostic Ultrasound System SSA-780A Used for routine diagnostic imaging
| Date | Oct 30, 2013 (initiated Aug 5, 2013) |
| Status | Terminated |
| 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 |
| Root cause | Device Design |
| Action | 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 Represen |
| Quantity | 427 units (1352 total) |
| Distribution | Nationwide Distribution including and US Territory Puerto Rico |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K092948 | APLIO MX SSA-780A, VERSION 1.0 Toshiba America Medical Systems, In.C, Oct 9, 2009 |