Company: GE Healthcare, LLC
Date of Enforcement Report: 9/25/2013
Class ll:
PRODUCT
GE Healthcare Discovery IGS 730 Cardiovascular X-Ray Imaging System. The angiography X-ray systems are indicated for use in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and non-vascular, diagnostic and interventional procedures. Additionally, with the OR table, the angiographic X-ray systems are indicated for use in generating fluoroscopic and rotational images of human anatomy for image guided surgical procedures. The OR table is suitable for interventional and surgical procedures. Recall Number Z2253-2013
REASON
GE Healthcare has recently become aware of a potential safety issue with respect to Discovery IGS 730 Imaging Systems. A patient data management error may prevent the Discovery IGS 730 Imaging System from booting on start-up or re-booting during procedure. The boot issue may occur when a large amount of patient data remains in the browser and is not deleted. The inability to boot the system may lead to a complete loss of real-time interventional imaging functionality. No injuries have been reported due to this issue.
RECALLING FIRM/MANUFACTURER
GE Healthcare, LLC, Waukesha, WI on 6/19/2013. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
4
DISTRIBUTION
Nationwide and Internationally
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