FDA Medical Device Recalls (openFDA)
Toshiba American Med Sys Inc: Toshiba Aplio 50 Digital Ultrasound System, SSA-700A with version 6 software
- Recall number
- Z-0986-2007
- Recalling firm
- Toshiba American Med Sys Inc
- Product
- Toshiba Aplio 50 Digital Ultrasound System, SSA-700A with version 6 software
- Status
- Terminated
- Initiated
- 2007-02-02
- Posted
- 2007-06-27
- Terminated
- 2012-04-18
- Reason
- When using the LV measurement function and making numerous measurements the value displayed on the image screen may on occasion not update correctly. The values that are stored in MDA (measurement display area) are correct and no issue has been reported with these values.
- Root cause
- Other
- Action
- Notification letters were sent to customers on February 2, 2007. Customers were informed of the safety issue regarding the possibility of incorrect measurement values being displayed on the active image screen while performing multiple measurements and instructed to verify actual results against the values stored in the MDA (measurement display area). Customers were also informed that a Toshiba Customer Service Engineer will contact them to schedule a software upgrade when software becomes available. If customers have any questions they were instructed to contact their Toshiba Customer Service Engineer or call (800) 421-1968 and ask for the Regulatory Affairs Department. Customers were also instructed to distribute this information to all users of the product and also with the Bio-medical Department at their facility.
- Quantity
- 45
- Distribution
- Nationwide
- Lot, serial or model codes
- Serial numbers: B2622263, B2622264, B2622265, B2622267, B2622269, B3522364, B3522365, B3522366, B3522369, B3522370, B3522372, B3522373, B3522402, B3522403, B3522404, B3522405, B3552542, B3552557, B3552558, B3552560, B3562595, B3562599, B3582672, B3582673, B3582674, C3592771, C3592772, C3592773, C3592774, D4553251, D4553252, D4553253, D4563327, D4563329, E4593563, E4593564, F4603654, F4603655, F4603656, F4613730, F4613731, F4613732, F5513813, G5523871 & G5523875
- 510(k) numbers
- ["K022400"]
- 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