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Terminated

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

FDA Recall Z-0982-05 · Posted 2005-07-13

Recalling FirmToshiba American Med Sys Inc
Recall StatusTerminated
Product CodeIYN
Date Initiated2005-05-23
Date Terminated2012-05-10
Product Quantity106

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.

Firm Action

Firm issued a recall letter which provided a procedural workaround, a software patch will be installed during routine service visits.

Root Cause

Other

Distribution Pattern

Nationwide. This is an imported product.

Official Source

View FDA Recall →

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

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