FDA (Devices) recall action 77599
The FDA (Devices) publishes a recall like this one as 5 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 5 pages.
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.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Toshiba American Medical Systems Inc. is recalling 307 APLIO 500 diagnostic ultrasound systems because they may display incorrect values when using the Continuous Trace method on Spectral Doppler.
Toshiba American Medical Systems is recalling XARIO 200 diagnostic ultrasound systems because the Continuous Trace method may display incorrect velocity trace values.
Toshiba American Medical Systems is recalling seven XARIO 100 diagnostic ultrasound systems because they may display incorrect values when using the Continuous Trace method for velocity measurements.
Toshiba is recalling 90 APLIO 300 diagnostic ultrasound systems because they may display incorrect velocity trace values when using the Continuous Trace method.
Toshiba is recalling 28 APLIO i-series diagnostic ultrasound systems because they may display incorrect velocity values when using the Continuous Trace method.