FDA-Device2013-08-28Class II
GE Healthcare, Precision 500D Product Usage: The Precision 500D is designed to perform radiographic and fluoroscopic x-ray examinations.
GE Healthcare, LLC
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
Sold states
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.
Affected count
445 (421 US, 24 OUS)
Manufactured in
3000 N Grandview Blvd, N/A, Waukesha, WI, United States
Products
GE Healthcare, Precision 500D Product Usage: The Precision 500D is designed to perform radiographic and fluoroscopic x-ray examinations.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1989-2013Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief