FDA Medical Device Recalls (openFDA)
Toshiba American Medical Systems Inc: TSX-301C Aquilion One (Vision Edition) Computed Tomography X-Ray System.
- Recall number
- Z-0972-2014
- Recalling firm
- Toshiba American Medical Systems Inc
- Product
- TSX-301C Aquilion One (Vision Edition) Computed Tomography X-Ray System.
- Status
- Terminated
- Initiated
- 2013-12-11
- Posted
- 2014-03-06
- Terminated
- 2014-10-16
- Reason
- Toshiba America Medical Systems, Inc. initiated this recall due to the failure of the parts used in the X-ray high-voltage generator. In some cases, X-ray exposure cannot be performed.
- Root cause
- Other
- Action
- Toshiba America Medical Systems, Inc. initiated this recall by sending "Urgent Medical Device Correction," letter dated December 11, 2013, informed customers of the recall by providing, the device name, serial number, problem statement, corrective action statement, and contact information. A customer reply form accompanied the recall notification letter. Strategy: The majority of the letters are sent via USPS return receipt mail. The letter contains a return reply form that is to be faxed to TAMS for retention. After two weeks contact will be made with each non responding location and a copy of the letter will be faxed to that location and the fax receipt will service as proof of notification. Upon release of the new part it will be assigned to a TAMS employee with instructions for implementation at each site. Each incident is assigned a unique task number and each task is tracked through to completion. In the event that a customer refuses the installation of the corrected software/hardware the customer would be requested to sign a service case record stating that the corrected software/hardware was refused. CDRH approves the CAP subject to the following condition: Notification of all dealers and purchasers is to be made within 15 working days of receipt of this letter in the manner specified in 21 CFR 1003.21 and 1003.22. For further questions please call (714) 730-5000.
- Quantity
- 8 units
- Distribution
- US Distribution including the states of: MD, WV, OH, CA, MN, IN, NY and WI.
- Lot, serial or model codes
- SERIAL NO.: 1CB1262006, 1DB1312033, 1DC1352070, 1DB1342060, 1DB1332049, 1DC1382081, 1DB1312027, 1DB1332045, 1DC1362073, 1CB12X2018.
- 510(k) numbers
- ["K132222"]
- PMA numbers
- not on file
- Product code
- JAK
- 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