FDA Medical Device Recalls (openFDA)
Toshiba American Medical Systems Inc: Software for SSH-880CV Aplio Artida; System Diagnostic Ultrasound
- Recall number
- Z-2203-2011
- Recalling firm
- Toshiba American Medical Systems Inc
- Product
- Software for SSH-880CV Aplio Artida; System Diagnostic Ultrasound
- Status
- Terminated
- Initiated
- 2010-01-06
- Posted
- 2011-05-19
- Terminated
- 2012-04-20
- Reason
- Toshiba America Medical Systems (TAMS) has become aware that the FLEX M software has reversed left and right annotation and post FLEX M measurement error, which may result in incorrect values.
- Root cause
- Software design
- Action
- The recall communication was initiated on 1/6/10 with Toshiba forwarding an Urgent: Medical Device Correction letter with attached Customer Notification Reply Form (via US Postal Service for US Customers) to all customers who purchased the FLEX-M mode on Aplio Artida Diagnostic Ultrasound System. The letter provides the customers with an explanation of the problem identified and an action to be taken. Customers were instructed to avoid performing M image measurement using images saved in FLEX-M mode until the corrective action is completed. If customers need to perform measurement for images saved in FLEX-M mode, they were instructed to use manual calibration. Customers were instructed to note that even though the corrective action is taken, the existing saved images (saved images before the corrective action is taken) are not modified. Therefore, when referring to the measured values on the images which are saved in FLEX-M mode before the corrective action is taken, customers were instructed to carefully handle the measurements results because they may be incorrect. Customers were instructed to complete the attached form and fax it to the toll free number at the top of the form. The form can also be sent via e-mail to raffairs@tams.com. If customers have any questions regarding the medical device correction letter, they can contact the Director of Regulatory Affairs at (800) 421-1968 or their local Toshiba representative.
- Quantity
- 28
- Distribution
- Nationwide Distribution -- Including states of IA, MT, PA, CA, OR, GA, LA, OH, TX, MA, OH, WI, and Puerto Rico.
- Lot, serial or model codes
- W1A0822031-33, W1A0822048-49, W1A0832056, W1A0842069-70, W1B0852071-80, W1B0862087-8, W1C0872103-08, W1C0882119-24, W1F0972204-06, W1F0972218-20, W1F0992260-62, W1F0992268, and W1F0992270-73.
- 510(k) numbers
- ["K090158"]
- 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