Events

Device Recall GE Healthcare, Precision 500D, Legacy, RFX, and SFX X. 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 GE Healthcare, 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
    66277
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0012-2014
  • 사례 시작날짜
    2013-08-30
  • 사례 출판 날짜
    2013-10-17
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2014-05-22
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=121932
  • 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, fluoroscopic, image-intensified - Product Code JAA
  • 원인
    Ge healthcare has recently become aware of a potential safety issue involving the spotfilm device power assist handle. there is a potential for the internal bolts on the power assist handle to be loose or to loosen and/or fall out. this issue, if present, can result in a loss of calibration and offset of the power assist handle and/or, under extreme condition, sticking of the handle in the on p.
  • 조치
    GE Healthcare sent an "Urgent Medical Device Correction" letter dated August 30, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were requested to inspect your power assist handle for either of the two conditions listed below. Immediately contact your local GE Healthcare Service Representative if any issue is found. 1. If you observe that the power assist handle plastic grip is loose relative to the mount, discontinue use. 2. If plastic grip is secure, but you observe erratic performance, (power assist unresponsive, drifting of spotfilm device with no command, or lock release always ON), you may continue to use the device with care. Use all safety precautions relative to application of the myelographic stop and the inhibit, table horizontal stop OFF. GE Healthcare will correct all affected systems at no cost to you. A GE Healthcare service representative will contact you to arrange for this correction. If you have any questions or concerns regarding this notification, please call one of the following phone numbers: United States: 800 437 1171 Japan: 0120 055 919 For other countries, please contact your local GE Healthcare Service Representative .

Device

Device Recall GE Healthcare, Precision 500D, Legacy, RFX, and SFX X.
  • 모델명 / 제조번호(시리얼번호)
    Serial # System ID  00000976624WK7 202884RF2410 00000977748WK3 202884RF2411 00000955594WK7 205877LRF2 00000965983WK0 207373RF1 00000969026WK4 215748LEG1 00000960066WK9 219416ADV 00000975683WK4 228809SR2 00000966338WK6 256235ORF1 00000967770WK9 301896RF 00000961102WK1 302654RF 00000972383WK4 303440BCHRM4 00000964398WK2 303730R3 00000958345WK1 304256RX1A 00000978812WK6 361552LEGD1 00000970377WK8 404321LEG2 00000973016WK9 408259RF1 00000963305WK8 408977RF5 00000963524WK4 414266RM03 00000963118WK5 417533BR2 00000969537WK0 507372LEG 00000959491WK2 518382SRM2 00000976668WK4 540862ARF6 00000966773WK4 561468RM4 00000972380WK0 606285LEGACY 00000966622WK3 619421RF1 00000957841WK0 708216GIRF1 00000983335WK1 713527PRF1 00000964482WK4 775738RM2 00000971676WK2 804289HDF4 00000978181WK6 804747DHP1 00000994573WK4 815740RF1 00000961772WK1 817472LEG1 00000963293WK6 850747ER1 00000975653WK7 856778RF2 00000965747WK9 864295GRRM4 00000973832WK9 904508LEGACY 00000962333WK1 904819RF1 00000970009WK7 907276RM3 00000953103WK9 912633MR3 00000978182WK4 915685ADV3 00000978314WK3 916784LEG 00000977043WK9 936321LEG1 00000963738WK0 941798RM2 00000982588WK6 956388RF1 00000966348WK5 972566RM11 00000962460WK2 RADNETRF130 00000963491WK6 RADNETRF137 00000978497WK6 651232RF4 00000983536WK4 703689RM03 00000011284GP7 210297BMCRF11 00000011281GP3 210297SEBRF3 00000985785WK5 281348P5001 00000014340GP4 308398RF 00000014337GP0 412641RF1 00000984897WK9 435637RM4 00000013713GP3 561863RF1 00000013860GP2 661633XR2 00000014347GP9 713636LBJ7 00000988380WK2 717272RF2 00000011676GP4 720854RF1 00000012513GP8 727823RM3 00000013045GP0 770793P500D 00000012418GP0 781744RF3 00000012521GP1 816348BRF1 00000009196GP7 817255NHPD1 00000013285GP2 828298RF4 00000011737GP4 850325RF4 00000013257GP1 850494WF4 00000014350GP3 856325P500 00000989504WK6 913676SRM4 00000013271GP2 956350VRF3 00000990179WK4 PC7479XR03 00000012826GP4 00105FLU01 00001009797WK0 303825P500 00000009180M31 202745PRE2 00000022650M36 207498P500 00000001835M38 208227ROOM6 00000005813M31 208455RF1 00000002639M33 208678500D 00000022309M39 209536P500 00000015302M33 215710AURORA2 00000002983M35 228377RF10 00000003052M38 228377RF9 00000021223M33 239343RF4 00000021093M30 239432RF11 00000020302M36 240566DF1 00000007194M34 252522LRF1 00000005274M36 256494P5R1 00000992217WK0 260373RF4 00000022744M37 270756P500 00000019347M34 281477MWBP500D 00000008963M31 281637SLSP500D 00000997107WK8 304647PRE 00000022017M38 314251MR2 00000007242M31 314996BW2 00000004648M32 318330RF2 00000008860M39 318473RD4 00000004529M34 337521RF2 00000990537WK3 404325EFL1 00000008599M33 404712GIPR 00000004863M37 404785WBP500D 00000002984M33 406863P500 00000017129M38 412623P500D1 00001001061WK9 414649P500 00000995345WK6 423926RF1 00000017643M38 434654RM4 00000011245M38 469624P500D1 00000019086M38 469764P5001 00000008136M34 484884P500 00000993344WK1 505521RF1 00000020464M34 505609P500 00001004238WK0 509473VR2 00000014498M30 512341RRRF1 00000021219M31 517543P500D 00001003383WK5 540829RF1 00000004233M33 561791RM3 00000011944M36 570824P500 00000004229M31 573468MBS1 00000993783WK0 573756P500 00000005270M34 574523EG2 00000006560M37 574523EG4 00000998427WK9 601288PRF6 00000014272M39 605867P500 00000990547WK2 606678RF2 00001003367WK8 607432GE1 00001003379WK3 607547RF1 00001004242WK2 608745P500 00000021027M38 608775RF500 00000995340WK7 609599RFP4 00000012810M38 609835LMCP500 00001000389WK5 615342P500D3 00000999391WK6 615342P500D4 00000005650M37 617499RF4 00000995344WK9 617732ENDO 00000018235M32 623433RF 00000002217M38 678454P500D1 00000008661M31 702653RF03 00000997661WK4 713359RF3 00000013216M37 713441MOP500DP 00000999916WK0 715847P500 00000018057M30 717270RF2 00000003982M36 717544HCRF6 00001000995WK9 719560RF1 00000002577M35 732840P5D 00000022957M35 740633P500 00000021220M39 757398RM4 00000006859M33 770228RM3 00000021094M38 770400P500D 00000020193M39 785458P500 00000006330M35 802524500D 00000019490M32 812450DRF10 00000998422WK0 812858PRF 00000014501M31 813571RM4 00000020937M39 814723P500 00000001967M39 815741P500 00001004951WK8 815756RM2 00000990278WK4 817255NHRM1 00000020187M31 817782P500 00001007260WK1 864366ARF2 00001003364WK5 864675SFWR2 00000014567M32 910671SERF5 00000008311M33 910907P500RM3 00000021357M39 910938CHP500 00000008197M36 928763WRF1 00001005392WK4 931766RF1 00000023455M39 941629P500 00000010128M37 951CD500 00000022652M32 978741SRF3 00000005653M31 978774RF1 00000991650WK3 JAC3E63 00000020191M33 RADNETRF1284 00000020576M35 RADNETRF1286 00000018006M37 RADNETRF182 00000011818M32 RM7GEP500 00000005493M32 SA2135RX02 00001002438WK8 416813PR500FL1 00000006690M32 IL1000XR06 00000007585M33 00044FLU01 00000007385M38 00065FLU01 00001023876WK4 925947RM2 00001027482WK7 504873TR4P 000000102558K2 337470RF2  00001024517WK3 303RRP5001  00001024518WK1 712362P500  00001024576WK9 815968P500E  00001024577WK7 210617RF1  00001024578WK5 215710AURORA2  00001024725WK2 217443URF5  00001024726WK0 402294EBRF5 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DCOSDI300000408 Not Available DCOSDI300000436 Not Available DCOSDI300000440 Not Available DCOSDI300000920 Not Available DCOSDI400000063 Not Available DCOSDI400000167 Not Available DCOSDI50000419 Not Available DCOSDI50000425 Not Available DCOSDI50000426 Not Available DCOSDI600000212 Not Available KPICT Not Available LBDEMO2 Not Available RADNETRF1206 Not Available RADNETRF1213 Not Available RADNETRF1225 Not Available RADNETRF1240 Not Available RADNETRF1254 194130WK1 RADNETRF186 Not Available 416284LS16 Not Available 506648L9A Not Available 514934BRAD3
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA (nationwided) including DC., and the countries of AUSTRALIA, CANADA, CHILE, GERMANY, CHANA, GUATEMALA, ICELAND, ISRAEL, ITALY, JAMAICA, JAPAN, RUSIAN FEDERATION, UNITED ARAB EMIRATES and UNITED KINGDOM.
  • 제품 설명
    GE Healthcare, Precision 500D, Legacy, RFX, and SFX X. || This table is intended for use in a diagnostic X-ray system to support patients during general purpose radiological procedures in the horizontal, vertical and trendelenburg positions. - The Expedio 500D is designed to perform radiographic and fluoroscopic x-ray examinations. - The Precision 500D R&F; X-ray System is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic examinations, including general R&F; and pediatric examinations. The Precision 500D R&F; X-ray Systems are intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic and fluoroscopic exposures of the whole body, skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position.
  • Manufacturer
    GE Healthcare, LLC

Manufacturer

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