FDA Medical Device Recalls (openFDA)
Toshiba American Med Sys Inc: Toshiba America Medical Systems (TAMS) Aquilion 32 CT system, computed tomography x-ray system.
- Recall number
- Z-1707-2008
- Recalling firm
- Toshiba American Med Sys Inc
- Product
- Toshiba America Medical Systems (TAMS) Aquilion 32 CT system, computed tomography x-ray system.
- Status
- Terminated
- Initiated
- 2007-10-01
- Posted
- 2008-09-29
- Terminated
- 2012-07-16
- Reason
- Excessive radiation: Intermittent shifting of CT numbers causes the actual dose to the patient to be greater than expected, when Sure Exposure option is used.
- Root cause
- Device Design
- Action
- Toshiba sent a letter to customers in July 2007, and sent field service representatives to update the Data Aquisition System in September/October 2007.
- Quantity
- 1203 total
- Distribution
- Worldwide distribution, including USA and Japan.
- Lot, serial or model codes
- All codes
- 510(k) numbers
- ["K982265"]
- 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