FDA Medical Device Recalls (openFDA)
Toshiba American Medical Systems Inc: Aquilion One: Aquilion TSX-301A, 64 System, X-Ray, Tomography. Toshiba American Medical Systems, Inc. A multislice CT system that supports whole-body scanning.
- Recall number
- Z-2895-2011
- Recalling firm
- Toshiba American Medical Systems Inc
- Product
- Aquilion One: Aquilion TSX-301A, 64 System, X-Ray, Tomography. Toshiba American Medical Systems, Inc. A multislice CT system that supports whole-body scanning.
- Status
- Terminated
- Initiated
- 2011-01-07
- Posted
- 2011-07-29
- Terminated
- 2012-08-17
- Reason
- Toshiba America Medical Systems (TAMS) is initiating a field correction for the TSX-301A and TSX-301B: Aquilion 64 System, X-Ray, Tomography because communication between reconstruction units in the system console may be broken due to failure of the optical conversion connector, resulting in a break of communication between units.
- Root cause
- Software design
- Action
- Toshiba America Medical Systems, Inc. sent an "Urgent Medical Device Correction" letter dated January 4, 2011 to all affected customers. The letter provides the customers with an explanation of the problem and the firms plan to install preventive measures and provided them with a Customer Reply form to send Toshiba. A representative will contact the customers for an appointment to install the measures to their CT system. For question on this recall call (800) 421-1968 or contact your local Toshiba Representative at (800) 521-1968.
- Quantity
- 6
- Distribution
- (USA) Nationwide Distribution including the states of WI, MO, TN, IA, AL, AZ, TX, and GA.
- Lot, serial or model codes
- 2DA1062208, 2DA107221, 2DA1072212, 2DB1082219, 2DB1082220, 2DB1082222
- 510(k) numbers
- ["K083282"]
- 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