Recall Z-0985-2007 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
Toshiba American Med Sys Inc
Toshiba Aplio 80 Digital Ultrasound System, SSA-770A with version 6 software
| Date | Jun 27, 2007 (initiated Feb 2, 2007) |
| Status | Terminated |
| Reason | When using the LV measurement function and making numerous measurements the value displayed on the image screen may on occasion not update correctly. The values that are stored in MDA (measurement display area) are correct and no issue has been reported with these values. |
| Root cause | Other |
| Action | Notification letters were sent to customers on February 2, 2007. Customers were informed of the safety issue regarding the possibility of incorrect measurement values being displayed on the active image screen while performing multiple measurements and instructed to verify actual results against the values stored in the MDA (measurement display area). Customers were also informed that a Toshiba Customer Service Engineer will contact them to schedule a software upgrade when software becomes available. If customers have any questions they were instructed to contact their Toshiba Customer Service |
| Quantity | 260 |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K041499 | SSA-770A, APLIO VERSION 5.5 Toshibamedical Systems Corporation, Jun 10, 2004 |