Recall Z-2712-2017 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
Toshiba American Medical Systems Inc
APLIO i-series: a) APLIO i700 TUS AI700 b) APLIO i800 TUS AI800 diagnostic ultrasound system
| Date | May 1, 2017 |
| Status | Terminated |
| Reason | When Continuous Trace method is used as the tracing method on Spectral Doppler in velocity trace measurement, an incorrect value may be displayed in the ultrasound systems and in the ultrasound workstations listed below. |
| Root cause | Software Manufacturing/Software Deployment |
| Action | Toshiba Medical sent an Urgent Medical Device Correction letter on May 1, 2017. The consignee is instructed not to use the Continuous Trace method for cardiac velocity trace measurements to quantify the MPG values. Modified software is being provided. A Toshiba service representative will contact the consignee to make an appointment to install the modified software to fix the problem. Customers were asked to complete the form and fax it to the toll-free number shown at the top of the form. The form can also be sent by email to RAffairs@tams.com. Customers with questions were instructed |
| Quantity | 28 units |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K161843 | Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.0 Toshibamedical Systems Corporation, Sep 21, 2016 |