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GE Healthcare, LLC recalls GE Healthcare, Innova 3100 and Innova 4100 systems. The Digital Fluoroscopic Imaging System is indicated for use in d
Recalled July 10, 2013 · FDA recall Z-1616-2013 · GE Healthcare
Hazard
GE Healthcare reported a potential safety issue due to temporary loss of X-Ray Imaging Modes during Collimator Auto-Calibration which affects Innova 3100 and Innova 4100 Systems. · FDA Class II
Units
48
Sold at
Worldwide distribution - USA including AZ, CA, CO, FL, ID, IL, ME, NV,NY, NC, OK, TN, UT, and WI; and Internationally to Canada, Chile, France, Germany, Italy, Japan, Korea, Norway and Spain.
Description
GE Healthcare reported a potential safety issue due to temporary loss of X-Ray Imaging Modes during Collimator Auto-Calibration which affects Innova 3100 and Innova 4100 Systems.
Product
GE Healthcare, Innova 3100 and Innova 4100 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.
Manufacturer(s)
GE Healthcare, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →