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U.S. Department of Health and Human Services

Enforcement Report - Week of August 28, 2013

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Event Detail

Event ID 65862
Product Type Devices
Status Ongoing
Recalling Firm GE Healthcare, LLC
City Waukesha
State WI
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-05-02
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern 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.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
GE Healthcare, Precision 500D Product Usage: The Precision 500D is designed to perform radiographic and fluoroscopic x-ray examinations. 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 00000013543GP4 00000013544GP2 00000013545GP9 00000013547GP5 00000013548GP3 00000013549GP1 00000013550GP9 00000013551GP7 00000013552GP5 00000013554GP1 00000013556GP6 00000013558GP2 00000013559GP0 00000013560GP8 00000013561GP6 00000013735GP6 00000013736GP4 00000013737GP2 00000013738GP0 00000013739GP8 00000013740GP6 00000013765GP3 00000013843GP8 00000013844GP6 00000013845GP3 00000013846GP1 00000013848GP7 00000013849GP5 00000013850GP3 00000013851GP1 00000013852GP9 00000013853GP8 00000014155GP6 00000014156GP4 00000014157GP2 00000014158GP0 00000014159GP8 00000014160GP6 00000014161GP4 00000014162GP2 00000014164GP8 00000014195GP2 00000014196GP0 00000014197GP8 00000014198GP6 00000014200GP0 00000014201GP8 00000014203GP4 00000014204GP2 00000014205GP9 00000014206GP7 00000014207GP7 00000014549GP0 00000014550GP8 00000014552GP4 00000014553GP2 00000014554GP0 00000014555GP7 00000014669GP6 00000014727GP2 00000014728GP0 00000014730GP6 00000014731GP4 00000014732GP2 00000014750GP4 00000014751GP2 00000014752GP0 00000014753GP8 00000014754GP6 00000014755GP3 00000014756GP1 00000014757GP9 00000014758GP7 00000098424WK3 00000098564WK1 00000984816WK9 00000984817WK7 00000984818WK5 00000984819WK3 00000984821WK9 00000984822WK7 00000984824WK3 00000984825WK0 00000984826WK8 00000984827WK6 00000984828WK4 00000984829WK2 00000984830WK0 00000984831WK8 00000984832WK6 00000984833WK4 00000984834WK2 00000985547WK9 00000985548WK7 00000985549WK5 00000985550WK3 00000985945WK5 00000985946WK3 00000985947WK1 00000985948WK9 00000985949WK7 00000985950WK5 00000985951WK3 00000985952WK1 00000985953WK9 00000985954WK7 00000985955WK4 00000985956WK2 00000986944WK7 00000986945WK4 00000987213WK6 00000987214WK4 00000987215WK1 00000987216WK9 00000987217WK7 00000987218WK5 00000987219WK3 00000987220WK1 00000987222WK7 00000987223WK5 00000987224WK3 00000987225WK0 00000987226WK8 00000987231WK8 00000987233WK4 00000987234WK2 00000987238WK3 00000987245WK8 00000987253WK2 00000987254WK0 00000987321WK7 00000987323WK3 00000987332WK4 00000987333WK2 00000987336WK5 00000987337WK3 00000987338WK1 00000988559WK1 00000988560WK9 00000988561WK7 00000988562WK5 00000988563WK3 00000988564WK1 00000988565WK8 00000988566WK6 00000988567WK4 00000988568WK2 00000988569WK0 00000988570WK8 00000988571WK6 00000988572WK4 00000988573WK2 00000988574WK0 00000988575WK7 00000988576WK5 00000988577WK3 00000988578WK1 00000988579WK9 00000988580WK7 00000988581WK5 00000989367WK8 00000989369WK4 00000989371WK0 00000989372WK8 00000989375WK1 00000989376WK9 00000989378WK5 00000989379WK3 00000989380WK1 00000989381WK9 00000989382WK7 00000989383WK5 00000989384WK3 00000989386WK8 00012966GP8000 00000002609GQ6 00000004108GQ7 00000009899GQ6 00000009902GQ8 00000009908GQ5 00000013252GP2 00000013555GP8 00000013847GP9 00000014154GP9 00000006749GQ6 00000010410GP9 00000989377WK7 00000006754GQ6 00000008891GP4 00000012812GP4 00000012841GP3 00000013546GP7 00000984815WK1 00000984823WK5 00000989368WK6 00000989370WK2 00000006759GQ5 00000013557GP4 00000012957GP7 Class II 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 a screw in the absence of the locking-nut. To date, no complaint or injury has been reported due to this issue. 445 (421 US, 24 OUS) Z-1989-2013
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