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Terminated

APLIO 500 TUS-A500 diagnostic ultrasound system

FDA Recall Z-2711-2017 · Posted None

Recalling FirmToshiba American Medical Systems Inc
Recall StatusTerminated
Product CodeIYN
Date Initiated2017-05-01
Date Terminated2023-10-11
Product Quantity307 units

Reason for Recall

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.

Firm 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 [email protected]. Customers with questions were instructed to call 800-521-1968.

Root Cause

Software Manufacturing/Software Deployment

Distribution Pattern

Nationwide Distribution

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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