FDA Medical Device Recalls (openFDA)
Toshiba American Med Sys Inc: Aplio Diagnostic Ultrasound System (SSA-700A and SSA-770A) with software version 6.0er001 and 6.0er002
- Recall number
- Z-0982-05
- Recalling firm
- Toshiba American Med Sys Inc
- Product
- Aplio Diagnostic Ultrasound System (SSA-700A and SSA-770A) with software version 6.0er001 and 6.0er002
- Status
- Terminated
- Initiated
- 2005-05-23
- Posted
- 2005-07-13
- Terminated
- 2012-05-10
- Reason
- 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.
- 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
- 106
- Distribution
- Nationwide. This is an imported product.
- Lot, serial or model codes
- Software versions 6.0er001 and 002
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- IYN
- Firm FEI
- 2020563
- Firm city
- Tustin
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28