FDA Medical Device Recalls (openFDA)
Toshiba American Medical Systems Inc: Toshiba TSX-30IC AQUlLlON ONE System, Computed Tomography X-Ray. This system supports Whole body scanning.
- Recall number
- Z-1068-2013
- Recalling firm
- Toshiba American Medical Systems Inc
- Product
- Toshiba TSX-30IC AQUlLlON ONE System, Computed Tomography X-Ray. This system supports Whole body scanning.
- Status
- Terminated
- Initiated
- 2012-11-14
- Posted
- 2013-04-08
- Terminated
- 2013-04-08
- Reason
- Due to a problem with the control software of the x-ray high-voltage generator, if scanning is performed with a tube current less than 30mA, the control software may detect an error and perform error processing even though the x-ray output is normal.
- Root cause
- Process design
- Action
- Toshiba American Medical Systems Inc. sent a Urgent Medical Device Correction letter dated November 14, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customer was informed a New software to prevent the occurrence of this issue will be installed on your system. Toshiba Service Representative will contact you for an appointment to install the New Software on your Aquilion One System. Please fax the return reply form to (877) 349-3054. We thank you for your urgent attention to this matter. If you have any further questions regarding this letter please call (800) 521-1968.
- Quantity
- 1 unit
- Distribution
- Distributed in the state of MD.
- Lot, serial or model codes
- Serial No: 1CB1262006
- 510(k) numbers
- ["K122109"]
- 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
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
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