Aplio MX Diagnostic Ultrasound System SSA-780A Used for routine diagnostic imaging
FDA device recall Z-0121-2014 · posted 2013-10-30 · Terminated
Recall details
- Recalling firm
- Toshiba American Medical Systems Inc
- 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
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- IYN
- Quantity affected
- 427 units (1352 total)
- Distribution
- Nationwide Distribution including and US Territory Puerto Rico
- Date initiated
- 2013-08-05
- Date posted
- 2013-10-30
- Date terminated
- 2016-06-28
- Location
- Tustin, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| APLIO MX SSA-780A, VERSION 1.0 (K092948) | Toshiba America Medical Systems, In.C | 2009-10-09 |