Company: Toshiba American Medical Systems Inc.
Date of Enforcement Report 6/15/2011
Class ll:
PRODUCT
1) Toshiba Infinix-i, INFX-8000C. The expected usage of these devices is for fluoroscopy studies for various anatomical regions of the human body. Recall # Z-1871-2011;
2) Toshiba Infinix-i, INFX-8000F. The expected usage of these devices is for fluoroscopy studies for various anatomical regions of the human body. Recall # Z-1872-2011;
3) Toshiba Infinix-i, INFX-8000V. The expected usage of these devices is for fluoroscopy studies for various anatomical regions of the human body. Recall # Z-1873-2011;
4) Toshiba Infinix-i, DFP-8000D. The expected usage of these devices is for fluoroscopy studies for various anatomical regions of the human body. Recall # Z-1874-2011
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.
RECALLING FIRM/MANUFACTURER
Toshiba American Medical Systems Inc., Tustin, CA, by letter beginning December 21, 2010. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
220 units
DISTRIBUTION
Nationwide
