Z-1871-2011

Toshiba Infinix-i, INFX-8000C The expected usage of these devices is for fluoroscopy studies for various...

Name: Z-1871-2011 Toshiba Infinix-i, INFX-8000C The expected usage of these devices is for fluoroscopy studies for various...
Creator: Toshiba American Medical Systems Inc
Published: 2010-12-21
License: https://open.fda.gov/license/

Canon Medical Systems USA, Inc. / initiated 2010-12-21 / Terminated

FDA source

Toshiba American Medical Systems Inc began a recall of Toshiba Infinix-i, INFX-8000C The expected usage of these devices is for fluoroscopy studies for various anatomical regions of the human body on 2010-12-21. The reason FDA records is "Under some conditions during high doses procedures the cumulative air kerma display may reach its maximum capability and fail to display the accrued value". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1871-2011
Status: Terminated
Initiated: 2010-12-21
Posted: 2011-04-15
Terminated: 2013-03-18
Recalling firm: Canon Medical Systems USA, 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.
Product code: JAA System, X-Ray, Fluoroscopic, Image-Intensified
Reason for recall: Under some conditions during high doses procedures the cumulative air kerma display may reach its maximum capability and fail to display the accrued value.
FDA 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 in commerce: 220 units Nationwide
Distribution: Nationwide Distribution
Product codes and lots: Software version 4.23.

Product code JAA

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)