Z-0982-05

Aplio Diagnostic Ultrasound System (SSA-700A and SSA-770A) with software version 6.0er001 and 6.0er002

Name: Z-0982-05 Aplio Diagnostic Ultrasound System (SSA-700A and SSA-770A) with software version 6.0er001 and 6.0er002
Creator: Toshiba American Med Sys Inc
Published: 2005-05-23
License: https://open.fda.gov/license/

Canon Medical Systems USA, Inc. / initiated 2005-05-23 / Terminated

FDA source

Toshiba American Med Sys Inc began a recall of Aplio Diagnostic Ultrasound System (SSA-700A and SSA-770A) with software version 6.0er001 and 6.0er002 on 2005-05-23. The reason FDA records is "If the measurement mode is started from the Doppler mode and then the sweep speed setting is changed by the assigned user function, the measurement of the time direction results don't correspond to the actual values". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0982-05
Status: Terminated
Initiated: 2005-05-23
Posted: 2005-07-13
Terminated: 2012-05-10
Recalling firm: Canon Medical Systems USA, Inc.
Product: Aplio Diagnostic Ultrasound System (SSA-700A and SSA-770A) with software version 6.0er001 and 6.0er002
Product code: IYN System, Imaging, Pulsed Doppler, Ultrasonic
Reason for recall: If the measurement mode is started from the Doppler mode and then the sweep speed setting is changed by the assigned user function, the measurement of the time direction results don't correspond to the actual values.
FDA root cause: Other
Action: Firm issued a recall letter which provided a procedural workaround, a software patch will be installed during routine service visits.
Quantity in commerce: 106
Distribution: Nationwide. This is an imported product.
Product codes and lots: Software versions 6.0er001 and 002

Product code IYN

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)