FDA Medical Device Recalls (openFDA)
Toshiba American Medical Systems Inc: Toshiba Aquilion CT System TSX-301A
- Recall number
- Z-0014-2016
- Recalling firm
- Toshiba American Medical Systems Inc
- Product
- Toshiba Aquilion CT System TSX-301A
- Status
- Terminated
- Initiated
- 2015-05-08
- Posted
- 2015-10-09
- Terminated
- 2016-10-26
- Reason
- If two specific operations are performed in multi-phase helical scanning, the acquired raw data may not be saved.
- Root cause
- Radiation Control for Health and Safety Act
- Action
- Toshiba America Medical Planned Action to bring defect into Compliance: a. A notification will be sent to all consignees with affected systems in compliance with 21 CFR1 003.21 upon approval by the Secretary. b. To correct this issue revised software will be installed on each system to prevent this occurrence from happening. Each consignee will be contacted by their Toshiba service representative for an appointment when the revised software becomes available. c. Each consignee will be advised to do the following until the corrective measures have been taken, i.e., revised software installed on their systems. CDRH approves the CAP subject to the following conditions: 1. 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. This office and the Food and Drug Administration (FDA) district office coordinator noted below are to be included in the notification. 2. Toshiba America Medical Systems, Inc. will implement this CAP by February 1, 2016. If you have any questions please contact your local Toshiba Representative at (800) 521-1968.
- Quantity
- 459
- Distribution
- US Distribution including Puerto Rico
- Lot, serial or model codes
- system software V6.0 or later
- 510(k) numbers
- ["K113466"]
- 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