Events

Device Recall GEHealthcare, Drapes and Sterile Covers 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
    51722
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1730-2009
  • 사례 시작날짜
    2008-08-29
  • 사례 출판 날짜
    2009-08-14
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-05-15
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=81090
  • 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
    Protective Cover, Barrier - Product Code MMP
  • 원인
    Ge healthcare has found that the sterile products manufactured by contour fabricators, inc. (cfi) for ge healthcare (gehc) may have sterile seals that could be compromised during the shelf life of the products. this issue could result in the product not maintaining its sterile state.
  • 조치
    Consignees were sent 8/29/08 a GE Healthcare "Urgent Recall Notice" dated August 15, 2008. The letter was addressed to Director / Manager of Radiology and Director of Surgery. The letter described the problem and provided a list of products, solutions and requested the return of the attached fax forms. In the event of any questions or concerns, a service team should be contacted at 800-874-7378 option #8.

Device

Device Recall GEHealthcare, Drapes and Sterile Covers
  • 모델명 / 제조번호(시리얼번호)
    all codes
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- USA, Canada, Australia, Bahamas, China, Hong Kong, Italy, Japan, Korea, Mexico, Malaysia, Singapore, and El Salvador.
  • 제품 설명
    GE Healthcare, Drapes and Sterile Covers || PART NUMBER DESCRIPTION || 00-900352-01 DRAIN BAG W/HOSE (2000/2500) 2.0 PE MATERIAL || 00-900352-01-OEC STRL, BAG, DRAIN WITH PLASTIC CLIPS AND HOSE 2000,2500 || 00-900352-02 STRL, BAG, DRAIN WITH METAL TABS || 00-900493-03 COVER DISPOSABLE X-RAY TUBE || 00-900605-01 UROFAST DRAIN BAG (UROFAST ONLY) || 00-900605-01-OEC STRL, BAG, DRAIN, WITH HOSE, UROFAST || 00-900885-01 URO2600 DRAIN BAG 2.0 PE MATERIAL || 00-900885-01-OEC STRL, BAG, DRAIN, URO2600 || 00-900943-01 STRL, COVER, CARM, HALF BAG, 36X80, 90,94,76 || 00-900974-01 STRL, DRAPING, MINI-CARM, KYBRD, BLK FTSW, 6600 || 00-901072-01 URO 2600 DISPOSABLES PACK 2.0 PE MATERIAL || 00-901072-01-OEC STRL, PACK, DISPOSABLES, UROVIEW 2600 || 00-901169-01 12 TUBE DRAPE (36X36) 2.0 PE MATERIAL || 00-901169-01-OEC STRL, COVER, DISPOSABLE, 12 INCH TUBE 9600 || 00-901268-01 DRAPE,STERIQUIK, STANDARD&SUPER-; || C,9600/7700 || 00-901390-01 STRL, DRAPING, KEYBOARD, FOOTSWITCH, 20PACK, 6600 || 00-901391-01 STRL, DRAPE, C-ARM ONLY, 6600 || 00-901392-01 STRL, COVER, KEYBOARD, 66,68 || 00-901501-01 9600/9800/SUPER C DISPOSABLES PACK 2.0 PE MATERIAL || 00-901501-01-OEC STRL, PACK, DISPOSABLES, MODEL 9800, 20 PACK || 00-901581-01-OEC STRL, COVER, DISPOSABLE, IR REMOTE, 9600, 9800 || 00901588-01 12 C ARM DISPOSABLES PACK 2.0 PE MATERIAL || 00-901588-01-OEC STRL, PACK, DISPOSABLES, 12 INCH, 20 PACK SCD 9600 || 00-901761-01 STRL, DISPOSABLES PACK, UROVIEW 2800 || 00-901831-02 STRL, COVER, FLUOROTRAK MONITOR, || DISPOSABLE BOX 10 PER PKG || 00-901832-01 STRL, APIX, COVER, DISPOSABLE CONTROLPANEL COVERS, REPLACEMENT PART CASE OF 25 || 00-901917-01 STRL, DRAPE, C-ARM, 6800 || 00-901918-01 MINIVIEW 6800 C-ARM CONSUMABLES PACK GRAY FOOTSWITCH || 00-901918-01-OEC STRL, DRAPE, 20 PACK, 6800 || 00-902752-01 STRL, RUI COVERS 25 COVERS || 00-902753-01 STRL, PACK, DISPOSABLE, 9800MD, 9 INCH 20 PACKS || 00-902754-01 STRL, PACK, DISPOSABLE, 9800MD, 12 INCH 20 PACKS || 00-902776-01 STRL, DRAPE, VASCULAR || 00-902864-01 STRL, DRAPE, HALF, C ARM, 9800 9600 || 00-902934-01 STRL, DRAPE, WORKSTATION, 20 PER BOX, 9900 || 1003135 STRL, BAG, FLAT PANEL || E7009AE STRL, DRAPE, AFM/CFM PEDESTAL, 25 PER BOX || E7009AF STRL, DRAPE, AFM/CFM JOYSTICK, 50 PER BOX || E7009AG STRL, DRAPE, LARGE DOME BAG, 20 PER BOX || E7009AH STRL, DRAPE, MEDIUM DOME BAG, 20 PER BOX || E7009AJ STRL, DRAPE, SMALL DOME BAG, 20 PER BOX || Sterile EO, Distributed by GE Medical Systems, Milwaukee, WI 53201, Manufactured by Contour Fabricators, Inc. Fenton, MI 48430. || The disposable sterile product provide a sterile barrier between the imaging device and sterile surgical field.
  • Manufacturer
    GE Medical Systems, LLC

Manufacturer

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