FDAFDA · Food and drugs·Recall number Z-1989-2013
GE Healthcare, Precision 500D Product Usage: The Precision 500D is designed to perform radiographic and fluoroscopic x-ray examinations.
Published August 28, 2013 · Recall initiated: May 2, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- GE Healthcare, LLC
- Distributor
- 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.
- Lot
- FMI# 10879: CRT Monitor Suspension Supporting Hardware Serial # 00000002608GQ8 00000002734GQ2 00000002735GQ9 00000002736GQ7 00000002838GQ1 00000003208GQ6 00000003209GQ4 00000004078GQ2 00000004079GQ0 00000004083GQ2 00000004084GQ0 00000004086GQ5 00000004087GQ3 00000004102GQ0 00000004103GQ8 00000004104GQ6 00000004105GQ3 00000004106GQ1 00000004107GQ9 00000004109GQ5 00000004873GQ6 00000004874GQ4 00000004875GQ1 00000004876GQ9 00000004878GQ5 00000004881GQ9 00000004882GQ7 00000005522GQ8 00000005523GQ6 00000005524GQ4 00000005525GQ1 00000005527GQ7 00000005528GQ5 00000005529GQ3 00000005530GQ1 00000005885GQ9 00000005886GQ7 00000005887GQ5 00000006565GQ6 00000006566GQ4 00000006742GQ1 00000006743GQ9 00000006744GQ7 00000006745GQ4 00000006746GQ2 00000006747GQ0 00000006748GQ8 00000006752GQ0 00000006753GQ8 00000006755GQ3 00000006756GQ1 00000006757GQ9 00000006758GQ7 00000007111GQ8 00000007112GQ6 00000007113GQ4 00000007114GQ2 00000007115GQ9 00000007116GQ7 00000007117GQ5 00000007118GQ3 00000007119GQ1 00000007121GQ7 00000007122GQ5 00000007123GQ3 00000007124GQ1 00000007125GQ8 00000007126GQ6 00000007127GQ4 00000007128GQ2 00000007130GQ8 00000007131GQ6 00000007132GQ4 00000007430GQ2 00000008338GQ6 00000008339GQ4 00000008340GQ2 00000008448GQ3 00000008449GQ1 00000008450GQ9 00000008451GQ7 00000008452GQ5 00000008453GQ3 00000008454GQ1 00000008455GQ8 00000008456GQ6 00000008713GQ0 00000008714GQ8 00000008715GQ5 00000008716GQ3 00000008717GQ1 00000008890GP6 00000008892GP2 00000009027GP4 00000009028GP2 00000009174GP4 00000009392GP2 00000009393GP0 00000009394GP8 00000009395GP5 00000009396GP3 00000009893GQ9 00000009894GQ7 00000009895GQ4 00000009896GQ2 00000009898GQ8 00000009900GQ2 00000009901GQ0 00000009903GQ6 00000009904GQ4 00000009905GQ1 00000009906GQ9 00000009907GQ7 00000009909GQ3 00000009910GQ1 00000009911GQ9 00000009912GQ7 00000010136GQ0 00000010137GQ8 00000010138GQ6 00000010139GQ4 00000010409GP1 00000010411GP7 00000010588GP2 00000010609GP6 00000010610GP4 00000010611GP2 00000010612GP0 00000010613GP8 00000011511GP3 00000011512GP1 00000011513GP9 00000011514GP7 00000011515GP4 00000011517GP0 00000011537GP8 00000011538GP6 00000011539GP4 00000011688GP9 00000012059GP2 00000012060GP0 00000012061GP8 00000012062GP6 00000012064GP2 00000012065GP9 00000012066GP7 00000012067GP5 00000012068GP3 00000012085GP7 00000012086GP5 00000012087GP3 00000012088GP1 00000012089GP9 00000012090GP7 00000012102GP0 00000012103GP8 00000012104GP6 00000012105GP3 00000012106GP1 00000012107GP9 00000012108GP7 00000012109GP5 00000012110GP3 00000012111GP1 00000012478GP4 00000012479GP2 00000012480GP0 00000012481GP8 00000012482GP6 00000012483GP4 00000012523GP7 00000012524GP5 00000012525GP2 00000012526GP0 00000012527GP8 00000012808GP2 00000012809GP0 00000012810GP8 00000012811GP6 00000012814GP0 00000012836GP3 00000012837GP1 00000012838GP9 00000012839GP7 00000012840GP5 00000012842GP1 00000012843GP9 00000012844GP7 00000012845GP4 00000012856GP1 00000012857GP9 00000012859GP5 00000012860GP3 00000012861GP1 00000012862GP9 00000012863GP7 00000012864GP5 00000012876GP9 00000012878GP5 00000012949GP4 00000012950GP2 00000012951GP0 00000012952GP8 00000012953GP6 00000012955GP1 00000012956GP9 00000012959GP3 00000012960GP1 00000012961GP9 00000012962GP7 00000012963GP5 00000012964GP3 00000012965GP0 00000012966GP8 00000012969GP2 00000012970GP0 00000012971GP8 00000012972GP6 00000012973GP4 00000012974GP2 00000012975GP9 00000012976GP7 00000012977GP5 00000013249GP8 00000013250GP6 00000013251GP4 00000013259GP7 00000013260GP5 00000013262GP1 00000013497GP3 00000013498GP1 00000013499GP9 00000013500GP4 00000013501GP2 00000013502GP0 00000013503GP8 00000013504GP6 00000013505GP3 00000013506GP1 00000013507GP9 00000013508GP7 00000013509GP5 00000013510GP3 00000013511GP1 00000013512GP9 00000013542GP6
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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