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GE Healthcare, LLC recalls GE Healthcare Precision 500D, Classical R&F System. Product Usage: The Precision 500D R&F X-ray System is intend
Recalled October 8, 2014 · FDA recall Z-0010-2015 · GE Healthcare
Hazard
GE Healthcare has become aware of a potential safety issue involving missing screws used for mounting the overhead Video Monitor to the tray assembly on a single monitor suspension. This issue affects the Precision 500D X-ray imaging systems. · FDA Class II
Units
204 (199 US, 5 OUS).
Sold at
Worldwide Distribution - US Nationwide - AL, AZ, AR, CA, CO, CT, FL, GA, HI, ID, IL, IN, IA, KS,KY, LA, MD, MA, MI, MN, MS, MO, NE, NV, NH, NJ, NM, NY, NC, OH, OR, PA, SC, TN, TX, UT, VA, WA, WV, WI and in the countries CANADA, GERMANY, UNITED KINGDOM.
Description
GE Healthcare has become aware of a potential safety issue involving missing screws used for mounting the overhead Video Monitor to the tray assembly on a single monitor suspension. This issue affects the Precision 500D X-ray imaging systems.
Product
GE Healthcare Precision 500D, Classical R&F System. Product Usage: The Precision 500D R&F X-ray System is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic examinations, including general R&F and Pediatric examinations.
Manufacturer(s)
GE Healthcare, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →