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GE Healthcare, LLC recalls GE Healthcare, Precision 500D Product Usage: The Precision 500D is designed to perform radiographic and fluoroscopic
Recalled August 28, 2013 · FDA recall Z-1989-2013 · GE Healthcare
Hazard
GE Healthcare has recently become aware of a potential safety issue involving the overhead Video Monitor Suspension involving Precision 500D Systems. There is a potential for the locking nut to loosen out of the Video Monitor Suspension yoke which could result in impact. This will not lead to an immediate fall of the suspended monitor since it will be held in place by the remaining bushing and · FDA Class II
Units
445 (421 US, 24 OUS)
Sold at
Worldwide Distribution - USA Nationwide in the states of AL, AK, AR, CA, CO, CT, FL, GA, HI, ID, IL IN, IA, KS, KY, LA, MD, MA, NMI, MN, MS, MO, NE, NV,NH,NJ, NM, NY, NC,ND, OH, OK OR, PA,SC, SD, TN, TX, UT, VA, WA, WV, WI, WY and the countries of CANADA, FRANCE GERMANY, GREAT BRITAIN ITALY, PANAMA, SAUDI ARABIA.
Description
GE Healthcare has recently become aware of a potential safety issue involving the overhead Video Monitor Suspension involving Precision 500D Systems. There is a potential for the locking nut to loosen out of the Video Monitor Suspension yoke which could result in impact. This will not lead to an immediate fall of the suspended monitor since it will be held in place by the remaining bushing and
Product
GE Healthcare, Precision 500D Product Usage: The Precision 500D is designed to perform radiographic and fluoroscopic x-ray examinations.
Manufacturer(s)
GE Healthcare, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →