Company: GE Healthcare, LLC.
Date of Enforcement Report 12/22/2010
Class ll:
PRODUCT
1) GE LightSpeed VCT Scanner System, models: a) 5212920-300, b) 5212920-310, c) 5311595-10. Composed of a gantry, patient table, operator console, computer, and PDU and includes image acquisition hardware, image acquisition and reconstruction software, associated accessories and connections/interfaces to accessories. Is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes, including Axial, Cine, Helical (Volumetric), Cardiac, and Gated acquisitions. Recall # Z-0368-2011;
2) GE BrightSpeed Excel/Edge/Elite Select / Elite CT Scanner System, models a) 2377708-560, b) 5377708-540, c) 5377708-560. Composed of a gantry, patient table, operator console, computer, and PDU and includes image acquisition hardware, image acquisition and reconstruction software, associated accessories and connections/interfaces to accessories. Is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes, including Axial, Cine, Helical (Volumetric), Cardiac, and Gated acquisitions. Recall # Z-0369-2011
REASON
GE has become aware of a potential set of circumstances that could cause x-ray continuation during an unexpected table stop on certain LightSpeed VCT and BrightSpeed systems
RECALLING FIRM/MANUFACTURER
Recalling Firm: GE Healthcare, LLC, Waukesha, WI, by letters dated September 2, 2010 and September 24, 2010.
Manufacturers: Yokogawa Medical Systems, Ltd., Hino-Shi, Tokyo, Japan;
Ge Hangwei Medical Systems Co., Ltd. Beijing, China;
GE Healthcare, LLC, Waukesha, WI. Firm initiated recall is ongoing..
VOLUME OF PRODUCT IN COMMERCE
1,014 units
DISTRIBUTION
Nationwide and internationally
