Device Recall COMPAX 40E Xray Systems 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 GE Medical Systems, LLC 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    52720
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0457-2010
  • 사례 시작날짜
    2009-07-30
  • 사례 출판 날짜
    2009-11-25
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2016-05-19
  • 사례 출처
    USFDA
  • 사례 출처 URL
  • 비고 / 경고
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • 데이터 추가 비고
    Non-Tilting Powered Radiographic Table - Product Code IZZ
  • 원인
    Ge healthcare has recently become aware that table lock safety features, which are provided with compax 40e x-ray systems, are not always being utilized and has resulted in unintended lateral tabletop movement that may impact patient safety.
  • 조치
    Consignees in US and Canada were sent on July 31, 2009 a GE Healthcare "Urgent Medical device Correction" letter dated July 30, 2009. The letter was addressed to Hospital Administrators/ Risk mangers; Radiology Department Mangers; Radiologists. The letter described the Safety Issue, Affected Product Details, Safety Instructions, Product correction, and Contact Information. The letter instructs customers that the table manual mechanical lock is provided with the system and should be engaged when loading or unloading patients to ensure the tabletop is stabilized and not moving. For the rest of the world, the customer letter was dated October 22, 2009 and was mailed October 30, 2009.

Device

  • 모델명 / 제조번호(시리얼번호)
    SYSTEM SERIAL  00000059301ES2  00000059308ES7  00000059350ES9  00000059655ES1  00000059657ES7  00000059682ES5  00000059699ES9  00000059701ES3  00000061281ES2  00000061285ES3  00000061288ES7  00000061292ES9  00000061312ES5  00000063191ES1  00000063197ES8  00000063200ES0  00000063201ES8  00000063202ES6  00000063218ES2  00000064023ES5  00000064031ES8  00000064045ES8  00000064050ES8  00000065211ES5  00000065212ES3  00000066155ES3  00000068507MA3  00000068516MA4  00000068518MA0  00000069848MA0  00000071567MA2  00000071568MA0  00000071569MA8  00000076137MA9  00000078106MA2  00000078109MA6  00000078110MA4  00000079274MA7  00000062896ES6  00000062904ES8  00000062905ES5  00000062907ES1  00000062908ES9  00000064086ES2  00000064683ES6  00000065711ES4  00000066419MA3  00000068887MA9  00000068890MA3  00000068894MA5  00000068899MA4  00000069099MA0  00000069872MA0  00000069881MA1  00000069905MA8  00000069906MA6 907276H02A 00000061271ES3 907580EF2 00000059667ES6 907458CAN 00000065215ES6 907458MDA1 00000072332MA0 256239RAD2 00000068511MA5 334418RAD 00000076127MA0 256315MPR1 00000068001MA7 205759CCRAD3 00000059307ES9 205759CCRAD5 00000069863MA9 501443VARAD 00000059694ES0 501663RAD 00000061299ES4 501622SJR1 00000068504MA0 501202RAD3 00000069855MA5 501987RAD 00000080592MA9 501886RAD 00000064037ES5 520674RAD 00000061277ES0 928672RM1  520737RAD 00000065509ES2 480844RM2 00000062922ES0 623465RAD1 00000068517MA2 602263RAD1 00000079271MA3 602277D219 00000069853MA0 480551RAD 00000069101MA4 602588RM1A 00000063190ES3 928724TSAILE 00000069875MA3 209448KR3 00000059670ES0 510943KWCMPX 00000059300ES4 916688KSR4 00000059340ES0 310854RAD  7079836181XR  760380R1 00000062912ES1 1684 00000059317ES8 510784KCMPX 00000061295ES2 949760RMH  209223RAD 00000065216ES4 831395RAD1 00000069856MA3 2306 00000067783MA1 2306  310363CMPX40 00000072335MA3 1785 00000059706ES2 2235 00000062890ES9 2253X 00000062909ES7 209225CMPX1 00000059318ES6 209225CMPX2 00000059334ES3 209225CMPX3 00000059331ES9 209225CMPX4 00000059332ES7 408945KMRAD 00000064681ES0 209577RAD1 00000068900MA0 209577RAD2  707258RAD 00000061294ES5 916784RAD9 00000061296ES0 510428OCX5 00000067779MA9 714634CMPX 00000059354ES1 510498PAC1 00000059693ES2 650853PR1 00000062911ES3 650853PR3 00000062906ES3 1579 00000059305ES3 415780KRAD  619556RAD1 00000071574MA8 619556RAD2 00000071572MA2 619532CAST1 00000066140ES5 619532RAD27 00000064036ES7 619545RAD1 00000064040ES9 619569RAD1 00000064676ES0 1709 00000059652ES8 1708 00000059653ES6 619421RAD1  619421RAD2  415202KR1 00000064081ES3 415202KR2 00000064096ES1 415476UCRAD2  408972CMPX 00000061282ES0 408885EVC 00000059345ES9 408885RAD3 00000059323ES6 408885RAD4 00000059325ES1 408885RAD5 00000059329ES3 408885RAD6 00000059313ES7 408885RAD7 00000059316ES0 408885RAD8 00000059315ES2 2235  650573C2 00000065714ES8 2416  707576RAD2 00000069864MA7 415742COMPX  303695ER1 00000062888ES3 303440BCHER1 00000063211ES7 303399RAD11  303839ER 00000059698ES1 303629ER2  303556RAD 00000059668ES4 303788RM7  970352RM6 00000075113MA1 719384RM1 00000061307ES5 970635RM5  719STCMPPH1 00000079294MA7 719556RM2 00000071571MA4 970879RAD 00000064027ES6 303450TOMO 00000062924ES6 203863RAD 00000061306ES7 301315RAD 00000063223ES2 202269ER 00000066141ES3 202269RAD1 00000063213ES3 202269RAD2 00000064026ES8 703697RAD2 00000059352ES5 202225RAD 00000068505MA7 863533RM3 00000064090ES4 941761MPH 00000068510MA7 813681CPX 00000062891ES7 813657RAD 00000062879ES2 FHFGRAD1 00000069900MA9 727725RAD3 00000069095MA8 305669RT4 00000064085ES4 727734R5 00000062917ES0 850883ER3 00000069093MA3 954492MPH2 00000068503MA2 954492MPH6 00000066144ES7 850862FER 00000064052ES4 352331MPH2 00000068514MA9 954987ER1 00000064091ES2 229639MPH 00000076170MA0 305293KW1 00000063210ES9 904636MPH 00000068508MA1 904636MPH1 00000078111MA2 904777RAD1 00000066152ES0 904777RAD2  904755ER 00000061308ES3 813828RAD1 00000072456MA7 407977RAD 00000059310ES3 407566ER2 00000059319ES4 407896ER3 00000059337ES6 407933FL2 00000059342ES6 850747GC1 00000067563MA7 850936ANXR 00000059351ES7 850416ERXR1 00000066151ES2 850283RM2 00000079270MA5 941483ER 00000069105MA5 941473RAD1  847885COMP 00000064051ES6 706854EVANS1 00000069882MA9 706733V3 00000064049ES0 706733V6  912466FT 00000063220ES8 770270RAD 00000062923ES8 706278HR8 00000059672ES6 706544MA1 00000075110MA7 706544WC1 00000075111MA5 912765ER1 00000063196ES0 478445CRM1 00000076173MA4 912257MR1 00000068898MA6 912257MR2 00000068895MA2 770736ESER1 00000062875ES0 912259SRM9 00000062913ES9 808329RM2 00000059650ES2 808935CPX1 00000061310ES9 808531RM1 00000069865MA4 808969RM1B56A 00000076172MA6 808433RM2A 00000061283ES8 808433ORTH1 00000065719ES7 808433RM3A 00000068888MA7 671366XRAY 00000067786MA4 808621RM3 00000059353ES3 808242RM1 00000069888MA6 712563RAD1 00000059669ES2 712324CMP40 00000061274ES7 208373RAD 00000063227ES3 208678RM2 00000061280ES4 208239RM3 00000064042ES5 312996OP1  312996OP2  3127733126 00000062919ES6 708833ER12 00000061276ES2 618662R1 00000064099ES5 708531RAD 00000064046ES6 708425MPH 00000066158ES7 708425ERMPH  918582MPH 00000063195ES2 815220RAD1 00000065718ES9 815664MR4 00000061289ES5 217788ED1  217788ED2  815758R1 00000065503ES5 815758R2 00000065221ES4 219824CLN 00000066154ES6 260373MPH 00000063189ES5 317630RAD3  317274R11 00000067996MA9 317274R10 00000067997MA7 765983RMC 00000064100ES1 219284RM2N 00000068501MA6 913684DPCOMPAX 00000069903MA3 785239TMC1 00000079268MA9 913541OPRM2 00000065709ES8 913317SRM1 00000059661ES9 913676VRT 00000060508ES9 502745M1 00000061273ES9 502745M3 00000059671ES8 502624MPH1 00000078108MA8 606257RC 00000059683ES3 502636ER1 00000059663ES5 502636ER2 00000059692ES4 502587JR8 00000059681ES7 502587JOCC2 00000064677ES8 606679RAD 00000064030ES0 606451RAD1 00000067787MA2 318473ERM1 00000068892MA9 318475R1  318436SA5 00000062894ES1 318327RM3 00000080597MA8 318327RM4 00000075109MA9 318335FDC 00000079275MA4 318675LER2  318675LSUWCR1  318648RM1 00000069898MA5 6175731 00000064080ES5 978287ERAD5 00000064089ES6 978287ERAD2  978937PSC 00000064092ES0 978937CDU 00000064079ES7 508693MVRAD 00000059349ES1 413781RM7 00000059707ES0 301981RAD2 00000067795MA5 301981RAD1 00000068891MA1 301981ORTHO 00000069862MA1 443481RAD 00000069874MA6 443442R1 00000066147ES0 443442R2 00000066150ES4 COMFORTXR1 00000071570MA6 COMFORTXR4 00000072328MA8 410278MPH  4105461 00000069849MA8 4105461  850881HR1 00000072337MA9 734475RAD 00000063219ES0 313593ER3 00000061275ES4 313593ER2 00000064034ES2 313593RAD1 00000063226ES5 313964MPH 00000065507ES6 517546VRT 00000064098ES7 616341MPH1 00000065506ES8 616341MPH2 00000065223ES0 616341MPHT 00000065502ES7 616341MPH3  517334RM3 00000064047ES4 517334RM4 00000063212ES5 517723CPX 00000068506MA5 810759ER1 00000066550MA5 507537MPH 00000064032ES6 612520N02 00000064074ES8 660885GX1 00000059346ES7 573815BR2 00000060495ES9 573556JCR1 00000059341ES8 913397DICRAD 00000063217ES4 417820ASC2 00000076171MA8 417837MCFPX1 00000078102MA1 228872OR4 00000059314ES5 662513R3 00000072338MA7 601883RT2 00000069880MA3 406238BSM3 00000069854MA8 406233MCR1  406338BX2 00000062921ES2 336625ER1 00000065511ES8 336625ER2 00000065510ES0 828213MMR13 00000069896MA9 828213MMR15  919575CMP 00000076136MA1 919575FCI1  TEMPID13  201754RAD4 00000059344ES2 443643MPH 00000067992MA8 443643ER 00000067780MA7 704638RX2 00000064048ES2 910907JCR1 00000059665ES0 910907RCRM2 00000078105MA4 910907CR1 00000062895ES8 910907WAR7 00000062918ES8 910907RCRM1  336794CTIRAD 00000069867MA0 828754CCOMP 00000059708ES8 919575XR55 00000062885ES9 252447ECRAD1 00000072450MA0 910417RAD1 00000063225ES7 828286RH1A 00000063228ES1 919934ER1 00000059328ES5 704873MPH 00000076134MA6 910343NHERC 00000066412MA8 919762DR4 00000063208ES3 336718FER1 00000061293ES7 402837MRAD 00000079269MA7 402362YMPH 00000064025ES0 603432P1 00000061297ES8 603778ER3 00000061313ES3 973450ER1 00000067993MA6 973450ER2 00000068002MA5 973844RAD 00000071573MA0 973625ER1 00000068500MA8 908527RAD1 00000059359ES0 908527RAD2 00000059309ES5 609723R1  973284RAD1  973DOCRM1 00000069100MA6 973DOCRM2 00000069106MA3 973726RAD1 00000059662ES7 505265CMPX 00000075112MA3 505632MPH 00000072457MA5 505786RAD 00000061311ES7 520697RAD 00000062897ES4 505287CMPX 00000059704ES7 702564RAD1 00000062881ES8 702564RAD2 00000062877ES6 702598RAD 00000063206ES7 702256RAD2 00000065209ES9 702452CMPX 00000062899ES0 E21445 00000059659ES3 M27586 00000064097ES9 718250ER1 00000069876MA1 718250RM5 00000064102ES7 718692RAD1 00000064088ES8 518761GR8 00000059357ES4 718883RAD1 00000069869MA6 718883RAD2 00000069870MA4 212821RAD 00000061309ES1 212746K211 00000059304ES6 212746L607 00000064101ES9 212746L609 00000064078ES9 516333800T 00000063207ES5 419562RAD3 00000064679ES4 614566CPX1  614760RAD 00000062884ES2 614566CPT 00000067794MA8 614566ER1 00000068889MA5 937208ER1 00000067792MA2 937208ER3 00000067791MA4 937208ER2  937279RAD1 00000065707ES2 419784RAD 00000068003MA3 414C4451 00000061301ES8 414C4451 00000061303ES4 414F00256 00000062876ES8 740286HJX1 00000067999MA3 740286HJX2 00000068000MA9 419227RM1 00000065710ES6 2162974X 00000061298ES6 440368CPX 00000066157ES9 440816MPH 00000064028ES4 937372ER 00000066142ES1 580421VR1 00000062920ES4 580421VR2 00000064077ES1 580481RM1 00000079267MA1 405359ER1 00000062901ES4 580458ROOM2 00000080595MA2 580458ROOM3 00000069885MA2 580442TMC  580458RR4  918683PXR1 00000062903ES0 405307NER1 00000076161MA9 405307NER2 00000076162MA7 405734TRAD1 00000078104MA7 580213R1  541757GSRM2  541472RAD1 00000069102MA2 541472RAD2 00000069107MA1 503472RAD1 00000067793MA0 503571EFK2 00000059690ES8 503571EFK3 00000059691ES6 503222RM4 00000059303ES8 503VARM10 00000061316ES6 503VARM2 00000061300ES0 503VARM9 00000069907MA4 541677RAD1 00000076131MA2 503588RAD 00000060500ES6 610770MPH 00000076129MA6 724282RAD 00000062898ES2 724284R5 00000064041ES7 717789MPH 00000063192ES9 717530MPH 00000063224ES0 717245R1WC 00000069883MA7 717267R1 00000062915ES4 570476RAD1 00000069902MA5 724983R2 00000066146ES2 717637R1 00000066145ES4 717633R1  724357RAD1 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00000059673ES4 972376VAER3 00000059689ES0 214648RAD 00000069871MA2 940384DR3 00000062910ES5 940384DR4 00000064082ES1 915595ERT 00000065713ES0 915568RAD1 00000076174MA2 254288MCRAD1 00000069892MA8 254288MCRAD2 00000069891MA0 817288DORTHO2 00000067788MA0 817551HMTOMO 00000062916ES2 817346TOMO 00000061291ES1 817922TOMO 00000061304ES2 409772TOMO  713794AA1 00000059664ES3 713722SB01A 00000067781MA5 713722SB02A 00000065705ES6 713704ER1192 00000063204ES2 281446HSRAD 00000072453MA4 210292WBV50 00000059358ES2 806725TOMO 00000069094MA1 956632COMPX  972548RAD 00000059680ES9 972698MPH2 00000076125MA4 512341RRTOMO  940676RCRM2 00000076167MA6 940676RCRM3 00000076164MA3 940676RCRM4 00000076130MA4 940676RCRM5 00000076132MA0 940676RCRM6 00000076163MA5 940676RCRM7 00000076169MA2 940676RCRM8 00000076168MA4 801224RM3 00000059336ES8 435637RM2 00000059348ES3 757668RM3 00000059343ES4 757668RM5A 00000069901MA7 757668RM4  THULERAD1 00000080591MA1 757398MVE 00000068896MA0 757953NE1 00000061272ES1 757953NORT 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00000063229ES9 01205RAD01 00000066028ES2 00967RAD01 00000068010MA8 00053RAD15 00000071138MA2 00233RAD06 00000071410MA5 00356RAD04 00000064958ES2 05270RAD01 00000063240ES6 05270RAD02 00000063241ES4 00059RAD03 00000068009MA0 00132RAD16 00000063231ES5 00490RAD05  10273RAD01 00000075171MA9 10020RAD01 00000063247ES1 00385RAD03 00000067977MA9 856070169 00000063276ES0  00000067989MA4  00000067990MA2 0853070232  0853070234  0853070235  0853070259  0853070265  0853070220  0853070231  0853070230  0853070239  0853070246  853070259 00000072339MA5 853070265 00000072454MA2 853070230 00000068509MA9 853070231 00000068515MA6 853070246 00000071566MA4 794170XR01 00000066159ES5 265050XR03 00000069091MA7 724010XR02 00000068013MA2 DPN37700 00000066160ES3 NP335802 00000068011MA6 ME208303 00000066027ES4 ME208306 00000067976MA1 ME833118 00000078216MA9 YE529802 00000068954MA7 FE416037 00000066850MA9 DPN03101 00000079197MA0 DPE73916 00000071412MA1 FE828407 00000071413MA9 CEZ11701 00000075901MA9 FPG16000 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  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- USA, including states of AL, AK, AZ, AR, CA, CO, CT, DC,FL, GA, HI, ID, IL , IN, IA, KS, KY, LA, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH,NJ, NM, NY, NC, OH, OK OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, and WY and countries of UNITED KINGDOM, THAILAND, TAIWAN, SWITZERLAND, SPAIN, SAUDI ARABIA, PUERTO RICO, PORTUGAL NEW CALEDONIA, MARTINIQUE, KOREA, JAPAN, JAMAICA, ITALY, ISRAEL, HONG KONG, HONDURAS, GREECE, GERMANY, FRANCE, EGYPT, DOMINICAN, CHINA, CANDA, BRAZIL AUSTRIA, and AUSTRALIA.
  • 제품 설명
    GE Medical Systems, COMPAX 40E X-ray Systems, Models; 2208203, 2208205, 2244282, 2244284, 2225863, 2225864 , 2225865, 2225870, 2225881, and 2225882. || Intended to be used for general purpose radiography and tomography.
  • Manufacturer

Manufacturer

  • 제조사 주소
    GE Medical Systems, LLC, 3000 N Grandview Blvd, Waukesha WI 53188-1615
  • 제조사 모회사 (2017)
  • Source
    USFDA