FDA Medical Device Recalls (openFDA)
Toshiba American Medical Systems Inc: Toshiba Infinix fluoroscopy DFP-8000D Digital Radiography System with version 3.40 or higher software. Controller for Infinix interventional angiography systems.
- Recall number
- Z-0005-2009
- Recalling firm
- Toshiba American Medical Systems Inc
- Product
- Toshiba Infinix fluoroscopy DFP-8000D Digital Radiography System with version 3.40 or higher software. Controller for Infinix interventional angiography systems.
- Status
- Terminated
- Initiated
- 2008-09-29
- Posted
- 2009-09-28
- Terminated
- 2012-10-04
- Reason
- Audible signal is not available at all times when using the HLC fluoroscopy mode. Special means of activation are not designed in for selection of High Level Controls, as required by regulation.
- Root cause
- Software design
- Action
- Toshiba issued a letter entitled Important Electronic Product Radiation Warning, September 30, 2008, explaining the issue. The customers were requested to reply to the letter via fax-back form, and a Toshiba service representative would install the corrective action.
- Quantity
- 129
- Distribution
- Nationwide
- Lot, serial or model codes
- Software version 3.40 or higher
- 510(k) numbers
- ["K081624"]
- PMA numbers
- not on file
- Product code
- MQB
- 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