Home / Recalls / Medical Devices
GE Healthcare, LLC recalls GE Healthcare Discovery IGS 730 Cardiovascular X-Ray Imaging System. The angiography X-ray systems are indicated for
Recalled September 25, 2013 · FDA recall Z-2253-2013 · GE Healthcare
Hazard
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 ma · FDA Class II
Units
4 (2 US, 2 OUS)
Sold at
Worldwide distribution: US (nationwide) including states of : PA and TN; countries of: FRANCE and SINGAPORE.
Description
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 ma
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.
Manufacturer(s)
GE Healthcare, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →