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

FDA device recall Z-1871-2011 · posted 2011-04-15 · Terminated

Recall details

Recalling firm

Toshiba American Medical Systems Inc

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.

Action taken

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.

Root cause

Radiation Control for Health and Safety Act

Status

Terminated

Product code

JAA

Quantity affected

220 units Nationwide

Distribution

Nationwide Distribution

Date initiated

2010-12-21

Date posted

2011-04-15

Date terminated

2013-03-18

Location

Tustin, CA