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U.S. Department of Health and Human Services

Class 2 Device Recall Toshiba Infinixi

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  Class 2 Device Recall Toshiba Infinixi see related information
Date Initiated by Firm December 21, 2010
Date Posted April 15, 2011
Recall Status1 Terminated 3 on March 18, 2013
Recall Number Z-1871-2011
Recall Event ID 58134
Product Classification Image-Intensified Fluoroscopic X-Ray System - Product Code JAA
Product Toshiba Infinix-i, INFX-8000C

The expected usage of these devices is for fluoroscopy studies for various anatomical regions of the human body.
Code Information Software version 4.23.
Recalling Firm/
Manufacturer		 Toshiba American Medical Systems Inc
2441 Michelle Dr
P.O. Box 2068
Tustin CA 92781-2068
For Additional Information Contact
714-730-5000
Manufacturer 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 Determined
Cause 2		 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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