APLIO 500 TUS-A500 diagnostic ultrasound system
Recall
- Recall Number
- Z-2711-2017
- Event Number
- 77599
- Firm
- Toshiba American Medical Systems Inc
- FEI Number
- 2020563
- Product Code
- IYN
- Status
- Terminated
- Root Cause
- Software Manufacturing/Software Deployment
- Initiated
- May 1, 2017
- Terminated
- October 11, 2023
- Address
- 2441 Michelle Dr PO Box 2068, Tustin, CA, 92780-7047
Description
APLIO 500 TUS-A500 diagnostic ultrasound system
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.
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 [email protected]. Customers with questions were instructed to call 800-521-1968.
Nationwide Distribution
307 units