Atlas FDA

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

FDA device recall Z-0982-05 · posted 2005-07-13 · Terminated

Recall details

Recalling firm
Toshiba American Med Sys Inc
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.
Action taken
Firm issued a recall letter which provided a procedural workaround, a software patch will be installed during routine service visits.
Root cause
Other
Status
Terminated
Product code
IYN
Quantity affected
106
Distribution
Nationwide. This is an imported product.
Date initiated
2005-05-23
Date posted
2005-07-13
Date terminated
2012-05-10
Location
Tustin, CA

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