Company:GE Healthcare, LLC
Date of Enforcement Report 4/18/12
Class ll:

PRODUCT
GE Healthcare Innova X-ray Imaging Systems. The Digital Fluoroscopic Imaging System is indicated for use in diagnostic and interventional angiographic procedures of human anatomy. It is intended to replace image intensifier fluoroscopic systems in all diagnostic or interventional procedures. This device is not intended for mammography applications. Recall # Z-1124-2012

REASON
It was discovered that when the Diamentor M4-KDK is installed on an Innova system the dose display is disabled on the certified Innova monitor and enabled on the Diamentor M4-KDK which is not certified as required by FDA regulation (Subpart J).

RECALLING FIRM/MANUFACTURER
GE Healthcare, LLC, Waukesha, WI, by letters beginning May 4, 2011. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
19 units

DISTRIBUTION
Nationwide