Device Recall Precision 500D

  • 모델명 / 제조번호(시리얼번호)
    FMI# 10879: CRT Monitor Suspension Supporting Hardware Serial 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  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    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.
  • 제품 설명
    GE Healthcare, Precision 500D || Product Usage: || The Precision 500D is designed to perform radiographic and fluoroscopic x-ray examinations.
  • Manufacturer
  • 1 Event

제조사

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

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 5 건

데이터에 대해 더 자세히 알아보기 여기

  • 모델명 / 제조번호(시리얼번호)
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US Nationwide including PR, GU and DC and the countries of: Afghanistan, Argentina, Australia, Austria, Belgium, Bermuda, Canada, Cayman Islands, Chile, Colombia, Czech Republic, Dominican Republic, Ecuador, Egypt, France, Germany, Ghana, Guatemala, Honduras, Indonesia, Ireland, Israel, Italy, Jamaica, Jordan, Korea (Republic of), Kuwait, Libyan Arab Jamahiriya, Malaysia, Malta, Mexico, New Zealand, Panama, Romania, Russia, Saudi Arabia, Spain, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Venezuela, Vietnam, and Yemen.
  • 제품 설명
    GE Healthcare Precision 500D and Advantx Legacy/Legacy-D Radiographic and Fluoroscopic Systems. || A universal diagnostic imaging system for radiographic and fluoroscopic examinations. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. || Legacy and Legacy D Table is intended for use in a diagnostic X-ray system to support patient during general purpose radiological procedures in the horizontal, vertical and Trendelenburg positions.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    all serial numbers
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    globally
  • 제품 설명
    Precision 500D Radiographic/Fluoroscopic X-ray System, model numbers 2225849, 005853. The Precision 500D system consists of an X-ray generator; angulating table with X-ray Tube, collimator and image intensifier; wall stand; overhead tube suspension; operator console and digital archive system.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US Nationwide including Washington D.C., Guam, and Puerto Rico. Outside the US to include: Afghanistan, Algeria, Argentina, Australia, Austria, Azerbaijan, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Burkina faso, Cameroon, Canada, Chile, China, Colombia, Costa Rica, Cote D'Ivoire, Croatia, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Finland, France, French Polynesia, Germany, Ghana, Greece, Guadeloupe, Guatemala, Guyana, Honduras, Hong Kong, Hungary, Iceland, Indonesia, Iran, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Korea (Republic of), Kuwait, Lebanon, Libyan Arab Jamahiriya, Macedonia, Malaysia, Mali, Malta, Martinique, Mexico, Morocco, Netherlands, New Caledonia, New Zealand, Niger, Norway, Palestine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Serbia, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Vietnam, Yemen.
  • 제품 설명
    Video Monitor Suspensions that may be on the following Fluoroscopic and Radiographic X-Ray systems: Precision 500D, Legacy, Prestilix, Monitrol, RFX, SFX, Tilt-C, Prestige VH, Prestige SI, and Prestige SII || Product Usage: || The systems are intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic examinations on both adult and pediatric subjects. The systmes are used 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
  • 모델명 / 제조번호(시리얼번호)
    System ID Model, Catalogue or Code #  828213AIRF2 2385123-2 309454FJRM1 2385123-2 217935WF1 2385123-2 434924UVAP1 2385123-2 717627RF2 2385123-2 608287PRE500 2385123-2 304473RF1 2385123-2 717627RF1 2385123-2 801807RM3 2385123-2 904858RM1 2385123-2 325658RF1 2385123-2 828322F6 2385123-2 623327RF1 2385123-2 864573MBR3 2385123-2 913696CRF1 2385123-2 817255NHRM1 2385123-2 217442VXF3A 2385123-2 509332PRF 2385123-2 405752P500 2385123-2 520498RF1 2385123-2 718518RF2 2385123-2 601426PRF1 2385123-2 256MIRF1 2385123-2 231876P500D1 2385123-2 765448DF1 2385123-2 404325EFL1 2385123-2 231935DF2 2385123-2 407321PRF5 2385123-2 903416PD1 2385123-2 970544RM2 2385123-2 314344DR10 2385123-2 423562RF1 2385123-2 608372P500 2385123-2 231876P500D2 2385123-2 765747PRE1 2385123-2 256974P1 2385123-2 972665BPPRE1 2385123-2 423562RF2 2385123-2 937352RM3 2385123-2 972665BPPRE2 2385123-2 314996MBRM2 2385123-2 JAC3D14 2385123-2 410871RF 2385123-2 434924UVAP2 2385123-2 256249CVRF 2385123-2 304526PRE1 2385123-2 843784RF 2385123-2 623327RF2 2385123-2 319235500D 2385123-2 606678RF2 2385123-2 507283P500 2385123-2 802674500D 2385123-2 JAC3E63 2385123-2 972665DDARF 2385123-2 314344DR11 2385123-2 804287RF1 2385123-2 757466RM7 2385123-2 757889RM8 2385123-2 320255F3 2385123-2 865458RF2 2385123-2 337948RF1 2385123-2 601288PRF6 2385123-2 225924RF2 2385123-2 586573P500 2385123-2 940764ROOMD 2385123-2 909793P5R6 2385123-2 602867RM1 2385123-2 740454PRE2 2385123-2 909793P5R4 2385123-2 717657PRE1 2385123-2 706733V8 2385123-2 704735P500D 2385123-2 336719NH135 2385123-2 713359RF3 2385123-2 719546P500 2385123-2 251580RF2 2385123-2 804594RM3 2385123-2 251580RF1 2385123-2 614293PRE4 2385123-2 541396RF1 2385123-2 443481RF4 2385123-2 617726PR64A 2385123-2 215538PRE1 2385123-2 775423RF 2385123-2 765348PR 2385123-2 503215P500D 2385123-2 316689RF500 2385123-2 520TMCRF1 2385123-2 573875CRM2 2385123-2 757886RM2 2385123-2 415600PRC1 2385123-2 414805P500 2385123-2 205387WRF6 2385123-2 352331SPINE 2385123-2 260373RF4 2385123-2 205939SVRF1 2385123-2 734712P500 2385123-2 262363P500 2385123-2 214352PREC1 2385123-2 7087471644 2385123-2 602588RM7 2385123-2 617414P1 2385123-2 512397ENDO1 2385123-2 573882UHRF1 2385123-2 7087471650 2385123-2 307778500D 2385123-2 803775RF2 2385123-2 609652P500 2385123-2 847742RM6 2385123-2 601477RF1 2385123-2 256265RF3 2385123-2 650723RF4 2385123-2 937352RM2 2385123-2 903614CSM500RM3 2385123-2 601288PRF5 2385123-2 314966JRM3A 2385123-2 915649PR1 2385123-2 412933RF2 2385123-2 360754XRM3 2385123-2 970945P500 2385123-2 606678RF1 2385123-2 972487BGOPRF 2385123-2 WH231P500D 2385123-2 405307P500 2385123-2 850878VARM1 2385123-2 843339P500 2385123-2 318214NRM1 2385123-2 615342P500D4 2385123-2 801408RM22 2385123-2 870972PRE1 2385123-2 870972PRE2 2385123-2 520228RF1 2385123-2 314251JDRM5 2385123-2 304647PRE 2385123-2 574772RF2 2385123-2 208786PREC 2385123-2 858966RF4 2385123-2 218634P500 2385123-2 972238PRO1 2385123-2 405272SRF1 2385123-2 386326RF1 2385123-2 910488VABE 2385123-2 252436RF2 2385123-2 713359DRF1 2385123-2 360570RF 2385123-2 914787500D 2385123-2 609599RFP4 2385123-2 818502RF1 2385123-2 856853P500C 2385123-2 605644P500 2385123-2 360493500D 2385123-2 985732P500 2385123-2 865531RF1 2385123-2 405949RFP4 2385123-2 843792RFPED 2385123-2 843792RFADULT 2385123-2 419251RF6 2385123-2 802775RM3 2385123-2 617414P2 2385123-2 561996RF1 2385123-2 225924RF1 2385123-2 605622RF 2385123-2 803778R1 2385123-2 804594RM2 2385123-2 615342RX1 2385123-2 479314P500A 2385123-2 715393PRE500 2385123-2 515263P5 2385123-2 804323P500A 2385123-2 956544P500 2385123-2 706544RM7 2385123-2 615342P500D3 2385123-2 415221PRC 2385123-2 260460PRE 2385123-2 856853P500D 2385123-2 858966RF5 2385123-2 901516U20 2385123-2 412269RXI 2385123-2 262656P500 2385123-2 405734P500 2385123-2 210572RF1 2385123-2 601740PRF1 2385123-2 414649P500 2385123-2 509473PREC 2385123-2 217876DRF1 2385123-2 901516S2 2385123-2 404466SFP5 2385123-2 801268RXI 2385123-2 419435P500 2385123-2 323268RF1 2385123-2 928283RM1 2385123-2 413534RF2 2385123-2 803581P500D 2385123-2 602344RM10 2385123-2 215537ERMCRF1 2385123-2 615451SUMRF2 2385123-2 701845P500 2385123-2 928453RF3 2385123-2 505983XRM6 2385123-2 608324P501 2385123-2 410225RF3 2385123-2 228467P500 2385123-2 828684RF2 2385123-2 740439R4 2385123-2 FHWPP500RF1 2385123-2 713791P500D3 2385123-2 713791P500D2 2385123-2 615451SUMRF1 2385123-2 713791P500D1 2385123-2 407518P500 2385123-2 607535P500 2385123-2 318214NRM2 2385123-2 704984P500D 2385123-2 608643P500 2385123-2 608745P500 2385123-2 920498P500 2385123-2 847618NWR6 2385123-2 541548RM1 2385123-2 505599P500 2385123-2 847842RAD5 2385123-2 FHALTRF5 2385123-2 928283RM2 2385123-2 740439R3 2385123-2 818907RF1 2385123-2 864675SFWR2 2385123-2 402481BEX4 2385123-2 856322P500 2385123-2 505841RM4 2385123-2 941473RF1 2385123-2 509473VR2 2385123-2 541768RM5MPI 2385123-2 207369RF1 2385123-2 801807RM1 2385123-2 210575MSTH2 2385123-2 406488SRF 2385123-2 912486EGA4 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2385123-2 732776R3 2385123-2 414328P500 2385123-2 386FHORF3 2385123-2 603569500D 2385123-2 704667RF2 2385123-2 228809MPI 2385123-2 205592DCPRF 2385123-2 907747P500 2385123-2 773STJP5D323 2385123-2 608775P500 2385125-2 847872RF2 2385125-2 603668C5 2385125-2 608785P500 2385125-2 718567RM2 2385125-2 865947RF1 2385125-2 724873RXI 2385125-2 310264P500 2385125-2 304598RF6 2385125-2 505521RF1 2385125-2 JMMCRF1 2385125-2 603669E10 2385125-2 973429RXI 2385125-2 505262P500 2385125-2 214590GI4 2385125-2 440827PREC 2385125-2 559353500D 2385125-2 630933P500D 2385125-2 217383CGI1A 2385125-2 425228RCW500D 2385125-2 608258P500 2385125-2 256997RM2 2385125-2 260373RF5 2385125-2 803776VRF5 2385125-2 818952RM5SP 2385125-2 304598RF2W 2385125-2 718963RF2 2385125-2 920568MPI 2385125-2 425740RF1 2385125-2 412623MPI 2385125-2 607432GE1 2385125-2 731661RM2 2385125-2 717637RF1 2385125-2 303320P5002 2385125-2 904719RF2 2385125-2 713704GILAB 2385125-2 802775MPI 2385125-2 615435RXI 2385125-2 402481BP500 2385125-2 671GMHAP5D 2385125-2 716568RF2 2385125-2 702382RF1 2385125-2 303320P5004 2385125-2 719776RM9 2385125-2 713441MMRF1 2385125-2 252482C500D 2385125-2 414649ENDOP1 2385125-2 573582AUDRF1 2385125-2 360417RF2 2385125-2 504988ENDO 2385125-2 504842ENDO 2385125-2 253ECN133995GI 2385125-2 843692GRF3 2385125-2 817347P500 2385125-2 865938RF1 2385125-2 RADNETXV1242 2385125-2 843431P500 2385125-2 915521RF2 2385125-2 216761PREC1 2385125-2 814234RF3 2385125-2 702360RF1 2385125-2 513686RM1 2385125-2 317582MPI 2385125-2 206764P500 2385125-2 213484RF6 2385125-2 660886FRF1 2385125-2 414325P500 2385125-2 412647GIMPI 2385125-2 COR369577 2385125-2 541743MPI 2385125-2 E31619 2385125-2 248465MPI 2385125-2 812522F1 2385125-2 207553P500 2385125-2 404712GIPR 2385125-2 315624P500D 2385125-2 650474SNCRXI1 2385125-2 281274MSP500D 2385125-2 859313P500B 2385125-2 210638RF2 2385125-2 650474SNCMPI1 2385125-2 320255F2 2385125-2 814234MPI 2385125-2 859313P500A 2385125-2 713441MMRF2 2385125-2 859887P500 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  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: US (nationwide) including Guam and DC but excluding CT, DE, HI and RI; and internationally to: AUSTRALIA, BULGARIA, CANADA, CHILE, DOMINICAN REPUBLIC, GERMANY, HONDURAS, IRELAND, ITALY, KUWAIT, LEBANON, MALTA, NAMIBIA, PORTUGAL, ROMANIA, RUSSIA, SAUDI ARABIA, SLOVAKIA, SPAIN, SWITZERLAND, TAIWAN, TURKEY, UNITED KINGDOM, VENEZUELA, and YEMEN.
  • 제품 설명
    GE Healthcare Precision 500D, Precision MPI & Precision RXI X-ray imaging systems. || 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
  • 모델명 / 제조번호(시리얼번호)
    Part number 5234960.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution
  • 제품 설명
    Precision 500D X-ray systems with under-table collimator part number 5234960. || The Precision 500D is designed to perform radiographic and fluoroscopic x-ray examinations.
  • Manufacturer