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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