Recall Z-0982-05 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
Toshiba American Med Sys Inc
Aplio Diagnostic Ultrasound System (SSA-700A and SSA-770A) with software version 6.0er001 and 6.0er002
| Date | Jul 13, 2005 (initiated May 23, 2005) |
| Status | Terminated |
| Reason | If the measurement mode is started from the Doppler mode and then the sweep speed setting is changed by the assigned user function, the measurement of the time direction results don't correspond to the actual values. |
| Root cause | Other |
| Action | Firm issued a recall letter which provided a procedural workaround, a software patch will be installed during routine service visits. |
| Quantity | 106 |
| Distribution | Nationwide. This is an imported product. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.