XARIO 100 TUS-X100 diagnostic ultrasound system
Hazard
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.
What You Should Do
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 to call 800-521-1968.
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Products
- Brand
- Toshiba American Medical Systems Inc
- UPC
- Serial Numbers: W5B16Z2555, W5B1712642, MXA1723100, MXA1723098, MXA1723101, MXA1723099, MXA1723097
Units Affected
7 units