FDA Medical Device Recalls (openFDA)
Toshiba American Medical Systems Inc: Toshiba Infinix-i, INFX-8000C The expected usage of these devices is for fluoroscopy studies for various anatomical regions of the human body.
- Recall number
- Z-1871-2011
- Recalling firm
- Toshiba American Medical Systems Inc
- Product
- Toshiba Infinix-i, INFX-8000C The expected usage of these devices is for fluoroscopy studies for various anatomical regions of the human body.
- Status
- Terminated
- Initiated
- 2010-12-21
- Posted
- 2011-04-15
- Terminated
- 2013-03-18
- Reason
- Under some conditions during high doses procedures the cumulative air kerma display may reach its maximum capability and fail to display the accrued value.
- Root cause
- Radiation Control for Health and Safety Act
- Action
- An Important: Electronic Product Radiation Warning notification was sent to all consignees. The letters described the reason for the recall and identified the affected product. The system software will be modified to allow the shift of the decimal to one position to the right allowing for a display of 99999.9 mGy. This will allow for the retention of the resolution until such time as the system exceeds the 9999.99 mGy range. A Toshiba Service person will contact customers when the software is available. Installed systems with the current version of software ( version 4.23) will begin to receive the corrected software April 2011. Previous versions of the software will begin to receive corrected software June 2011. The software will be provided free of charge. Questions related to the letter should be directed to the Regulatory Affairs Department at 800-421-1968.
- Quantity
- 220 units Nationwide
- Distribution
- Nationwide Distribution
- Lot, serial or model codes
- Software version 4.23.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JAA
- 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