Data Foundry

Medical device recalls 2017

APLIO 300 TUS-A300 diagnostic ultrasound system — Class II medical device recall Z-2710-2017

Terminated recall by Toshiba American Medical Systems Inc, reported 2017-07-19, distributed nationwide. When Continuous Trace method is used as the tracing method on Spectral Doppler in velocity trace measurement,

Recall numberZ-2710-2017
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmToshiba American Medical Systems Inc, Tustin, CA, United States
Recall initiated2017-05-01
Classified2017-07-10
Reported by FDA2017-07-19
Terminated2023-10-11
DistributedNationwide (US)
Quantity90 units
Serial numbersAAA1652011, AAA1652012, AAA1652013, AAA1652014, AAA1652015, AAA1672026, AAA1672027, AAA1672028, AAA1672029, AAA1672030, AAA1672031, AAA1672032, AAA1672033, AAA1672034, AAA1672035, AAA1672036, AAA1672037, AAA1672038, AAA1672040, AAA1682041, AAA1682042, AAA1682043, AAA1682044, AAA1682045, AAA1682046 and 65 more

Product

APLIO 300 TUS-A300 diagnostic ultrasound system

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2710-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.