Events

Device Recall GE Healthcare Proteus XR/a 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 GE Healthcare 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
    70514
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1248-2015
  • 사례 시작날짜
    2015-01-30
  • 사례 출판 날짜
    2015-03-06
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2015-09-15
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=133953
  • 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
    System, x-ray, stationary - Product Code KPR
  • 원인
    Potential breakage of the steel cable which supports the bucky device in certain wall stands of proteus xr/a x-ray imaging systems. a fall of a bucky while the system is in use could result in an injury to a patient or operator.
  • 조치
    Consignees were sent on 1/30/2015 a GE Healthcare "Urgent Medical Device Correction" letter GEHC Ref#17108 dated January 30, 2015. The letter was addressed to Hospital Administrators/Risk Managers, Managers of Radiology/Cardiology, and Radiologists/Cardiologists. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information. For questions contact 800-437-1171. Outside the US contact your local GE Healthcare Service Representative.

Device

Device Recall GE Healthcare Proteus XR/a
  • 모델명 / 제조번호(시리얼번호)
    Mfg Lot or Serial # System ID 00000014277HL8 503246PRO 00000014127HL5 202715PRO 00000013133HL4 206215RM1 00000013085HL6 206543HECED 00000014123HL4 208785RAD 00000014689HL4 208882GX1A 00000010591HL6 208893RAD2 00000014556HL5 209943SJRM2 00000013410HL6 214320RAD1 00000014413HL9 215918RAD1 00000014555HL7 215918RAD1 00000014684HL5 215918RAD2 00000014116HL8 216343R3 00000014276HL0 216343R4 00000013780HL2 217258SR3 00000024745HL2 217333LXR2 00000014020HL2 219284PRO1 00000014687HL8 225638R1 00000014119HL2 248652PROT3 00000014679HL5 262321RAD1 00000015410HL4 281392PRO 00000014424HL6 304257PROT 00000011358HL9 304354PROD 00000015166HL2 309655FNCR1 00000015168HL8 309655FNCR2 00000012515HL3 313369PROT 00000013910HL5 314768MRM8 00000014562HL3 314966JRM2A 00000011363HL9 318425LR1 00000013785HL1 319382PROTXR 00000014412HL1 330270PX 00000015409HL6 330438R3 00000014282HL8 330489XR3 00000014423HL8 330675PX 00000011060HL1 336768OSAB 00000010841HL5 336768OSCD 00000011055HL1 336768OSEF 00000010842HL3 336768OSGH 00000014686HI0 352401RAD3 00000011577HL4 360414SJRM4 00000015171HL2 360425LRP 00000013908HL9 402481PLRAD 00000015055HL7 404624METRO1 00000011195HL5 405447ORT 00000014283HL6 405744OSU 00000015047HL4 405949BCH 00000011580HL8 408636PROTEUS 00000015420HL3 414266RM8 00000013094HL8 419228LMP 00000014122HL6 419251RAD1 00000011198HL9 419946PRO2 00000013393HL4 425883ER 00000014128HL3 440835RAD1 00000014682HL9 440988RAD 00000015062HL3 502587JHC 00000012526HL0 502868RAD2 00000013390HL0 505272RM1 00000013610HL1 505835RM1 00000012524HL5 509684MC2 00000011359HL7 509684MCC1 00000014022HL8 517463RM3 00000013611HL9 517545RMONE 00000011199HL7 517684RM1 00000012510HL4 518292RAD2 00000012513HL8 518292RAD4 00000014683HL7 518483RAD 00000015050HL8 518583RAD7 00000012511HL2 518608RAD1 00000011177HL3 520742PROTEUS 00000014415HL4 520886PRO 00000013909HL7 570321TOMO 00000013600HL2 603352KC02 00000012509HL6 606474BFM 00000014021HL0 608647RAD 00000014115HL0 610280PROT1 00000013783HL6 610377PRO 00000013870HL1 614898PROT 00000014114HL3 615735PROT1 00000014685HL2 615781SHPROT 00000012865HL2 618242GS3 00000013791HL9 620343ER1 00000010882HL9 630213OAD4 00000012507HL0 630653OAD3 00000013781HL0 660679PROT 00000012690HL4 702434CAMP 00000015056HL5 702731RAD1 00000014419HL6 703698PRO1 00000015169HL6 706276NGR1 00000015053HL2 706886SR1 00000013596HL2 716275NEWER1 00000013868HL5 716477RAD 00000015063HL1 718262CLINIC 00000014559HL9 718830PROTEUS 00000013388HL4 740454PROT 00000014120HL0 740HOCPRO 00000015061HL5 760366ER 00000013088HL0 770270NR2 00000015762HL8 773967XRD3 00000013096HL3 775982PROT1 00000015165HL4 775982PROT4 00000015408HL8 801262RM3 00000011562HL6 801408RAD2 00000012514HL6 808974PRO 00000015178HL7 810421RAD 00000013090HL6 810484RM1 00000013086HL4 810484RM2 00000014411HL3 810484RM3 00000012536HL9 810758PROT 00000013914HL7 810985RAD 00000013400HL7 8149382O 00000011357HL1 815439RAD 00000013873HL5 816932SRM2 00000015172HL0 817447RAD 00000012517HL9 817605RAD 00000014417HL0 845887PRO 00000013608HL5 863419PRO 00000011058HL5 865425RAD1 00000011059HL3 865425RAD2 00000013591HL3 865544ER1 00000015174HL6 904819RAD 00000013913HL9 906485RAD 00000013391HL8 907264PROTEUS 00000013087HL2 908277RAD1 00000014117HL6 913791ORM4 00000012684HL7 915573RAD1 00000012686HL4 915573RAD2 00000013874HL3 919553WRAD1 00000014275HL2 925370LMRAD1 00000012521HL1 941793RAD 00000013594HL7 970521RM1 00000015421HL1 973971PED1 00000015052HL4 14308PROT1 00000015059HL9 14308PROT2 00000013387HL6 204325RAD2 00000011570HL9 306695RAD 00000011572HL5 418668PROTEUS 00000012683HL9 506466RM1A 00000014422HL0 519322PRO 00000011568HL3 519364GEN 00000013911HL3 705789RAD2 00000011579HL0 709897PROTEUS 00000014561HL5 807727RAD1 00000011354HL8 819563DPROTEUS 00000011196HL3 905468RAD 00000014416HL2 905732RAD 00000012528HL6 905852RAD 00000015058HL1 26329XR1 00000015417HL9 CS1147RX01 00000011181HL5 M4496931 00000013396HL7 CC3081XR02 00000011056HL9 HC1413XR01 00000012508HL8 HC7935XR01 00000011365HL4 HDAR01XR02 00000011362HL1 PX1401XR01 00000013409HL8 H2064RAD01 00000013790HL1 0828070086 00000014418HL8 HU1113RX01 00000013395HL9 IE1019RX02 00000011192HL2 IE1039RX01 00000012516HL1 A5109116 00000012505HL4 A5109117 00000015403HL9 A5113124 00000014017HL8 XU0005 00000013875HL0 XU0007 00000015176HL1 XU0008 00000013598HL8 0920079043 00000013593HL9 0920079044 00000014113HL5 PPR58501 00000015170HL4 PPR59009 00000015064HL9 PPR59010 00000013134HL2 RU1754RX01 00000012685HL4 SA1220RX09 00000015405HL4 SK1029RX01 00000013095HL5 9P252500 00000011355HL5 CP714307 00000014121HL8 DE658838 00000015407HL0 DEH35102 00000015057HL3 DEN01309 00000015413HL8 DEN01310 00000014552HL4 FE394804 00000010653HL5 FPG72301 00000015173HL8 MEX16906 00000012527HL8 YE151109 00000013597HL0 YE637005 00000015048HL2 00115RAD02 00000015167HL0 00115RAD03 00000011356HL3 00126RAD02 00000014690HL2 00160RAD06 00000010329HL1 00433RAD02 00000015175HL3 00832RAD02 00000012531HL0 01006RAD01 00000013392HL6 10259RAD02
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution-US (nationwide) including the states of AK, AZ, CA, CO, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MD, MI, MO, NC, NE, NH, NJ, NM, NV, NY, OH, OK, PA, TN, TX, UT, VA, WA, WI,and WV, and the countries of ARGENTINA, CANADA, CHILE, CZECH REPUBLIC, FRANCE, GERMANY, GREECE, HONG KONG, HUNGARY, IRELAND, ITALY, JAPAN, NEW ZEALAND, PORTUGAL, RUSSIA, SAUDI ARABIA, SLOVAKIA, SPAIN, and UNITED KINGDOM.
  • 제품 설명
    GE Healthcare Proteus XR/a with wall stand model number 2260354. || Intended for use in generating radiographic images of human anatomy in all general purpose diagnostic procedures. This device is not intended for mammographic applications.
  • Manufacturer
    GE Healthcare

Manufacturer

GE Healthcare
  • 제조사 주소
    GE Healthcare, 3000 N Grandview Blvd, Waukesha WI 53188-1615
  • 제조사 모회사 (2017)
    General Electric Company
  • Source
    USFDA