Company:Toshiba American Medical Systems Inc .
Date of Enforcement Report4/3/2013
Class ll:

PRODUCT

Toshiba Infinix-i X-Ray System. A radiographic and fluoroscopic x-ray system for use in diagnostic and angiographic procedures. Recall Number Z-0994-2013

REASON
Lost and incorrect images. When using the “F-Rec” fluoroscopy image acquisition recording option in the “manual mode” an infrequent software error may cause images from another study to be displayed on the monitor. The acquired images may be lost requiring additional image acquisitions to be performed.

RECALLING FIRM/MANUFACTURER
Toshiba American Medical Systems Inc., Tustin, CA, on 11/8/2012. Voluntary: Firm Initiated recall has been terminated.

VOLUME OF PRODUCT IN COMMERCE
95 units

DISTRIBUTION
Nationwide

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