CompanyGE Medical Systems
Date of Enforcement Report 1/28/2009
Class:ll
PRODUCT
a) GE Innova 2100IQ Versatile Cardiac and Vascular Imaging System. The system consists of a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector. The product is indicated for use in generating fluoroscopic images of human anatomy for vascular angiography diagnostic and interventional procedures and optionally, rotational imaging procedures. It is also intended for generating fluoroscopic images of human anatomy for cardiology, diagnostic and interventional procedures. Recall # Z-0473-2009;
b) GE Innova 3100 / 3100 IQ, Cardiovascular Imaging System. The system consists of a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector. The product is indicated for use in generating fluoroscopic images of human anatomy for vascular angiography diagnostic and interventional procedures and optionally, rotational imaging procedures. It is also intended for generating fluoroscopic images of human anatomy for cardiology, diagnostic and interventional procedures. Recall # Z-0474-2009;
c) GE Innova 4100 /4100 IQ. , The system consists of a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector. The product is indicated for use in generating fluoroscopic images of human anatomy for vascular angiography diagnostic and interventional procedures and optionally, rotational imaging procedures. It is also intended for generating fluoroscopic images of human anatomy for cardiology, diagnostic and interventional procedures. Recall # Z-0475-2009
REASON
Software error, computer: GE Healthcare has become aware of an issue with Error Management affecting the Innova 2100, 3100/3100 IQ & 4100/4100IQ. It was reported that when the foot switch was pressed, the live monitor screen was blank and it looked like there were no X-rays being emitted. But the message “Acquisition in progress” was displayed on the DL monitor, even after the foot switch was released. The operator had to reset the system to clear the message. This issue raises potential safety concerns in particular in the X RAY and motion controls if the error management does not work properly. No injury was reported. However, the patient received a low, unnecessary x-ray dose.
RECALLING FIRM/MANUFACTURER
Recalling Firm: GE Medical Systems, LLC, Waukesha, WI, by letter dated February 28, 2008.
Manufacturer: GE Medical Systems, SCS, Buc Cedex, France. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
1,129 units
DISTRIBUTION
Nationwide and Internationally
