FDA Medical Device Recalls (openFDA)
Toshiba American Medical Systems Inc: TSX-301A/2 Aquilion One CT System. The TSX-30IAl2 is a whole body CT scanner. This device captures cross sectional volume data sets. The device consists of a gantry, patient couch (table) and peripheral cabinets used for data processing and display. This device is intended to produce cross sectional volume sets of the anatomy. Additionally the system, when used by a trained professional, is capable of proving data for dynamic and perfusion studies of organs and extremities.
- Recall number
- Z-2468-2012
- Recalling firm
- Toshiba American Medical Systems Inc
- Product
- TSX-301A/2 Aquilion One CT System. The TSX-30IAl2 is a whole body CT scanner. This device captures cross sectional volume data sets. The device consists of a gantry, patient couch (table) and peripheral cabinets used for data processing and display. This device is intended to produce cross sectional volume sets of the anatomy. Additionally the system, when used by a trained professional, is capable of proving data for dynamic and perfusion studies of organs and extremities.
- Status
- Terminated
- Initiated
- 2008-05-13
- Posted
- 2012-09-27
- Terminated
- 2012-09-27
- Reason
- The SureStart function may not operate in the usual manner, and you may obtain abnormal analysis results when using the cerebral blood flow analysis function.
- Root cause
- Software design
- Action
- Toshiba American Medical Systems, Inc. sent an "URGENT: MEDICAL DEVICE CORRECTION" letter to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. customers: The firm advised customers to take the following temporary measures to avoid issues until a corrective action has been taken: I. In SureStart: " Perform scanning with Observation Direction set to VFF when the Patient Insertion Direction and Observation direction are FF. " Perform scanning with the Observation direction set to VFH when the Patient Insertion Direction and Observation Direction are HF. 2. When acquiring images for 4D perfusion analysis: " Perform scanning with the Scan Direction set to OUT when the Patient Insertion Direction and Scan Direction are HF. Perform scanning with the scan direction set to IN when the Patient Insertion Direction and Scan Direction are FF. Contact the firm at (800) 421-1968 for questions regarding this issue.
- Quantity
- 3 units
- Distribution
- Nationwide distribution: USA including states of: MA, MD, and NV.
- Lot, serial or model codes
- Item number TSX-301 A/2D Serial Numbers: 2DA0792004, 2DA07X2005, 2DA07Y2010, 2DA0792002, 2DA07X2008, 2DA0842023.
- 510(k) numbers
- ["K072606"]
- 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