FDA-Device2013-07-10Class II
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.
GE Healthcare, LLC
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.
Sold states
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.
Affected count
48
Manufactured in
3000 N Grandview Blvd, N/A, Waukesha, WI, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1616-2013Don't want to check this manually?
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