Device Recall GE BRIGHTSPEED DELIGHT CT SCANNER SYSTEM 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
    57591
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2214-2011
  • 사례 시작날짜
    2011-01-19
  • 사례 출판 날짜
    2011-05-19
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2012-07-10
  • 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
    System, x-ray, tomography, computed - Product Code JAK
  • 원인
    Ge healthcare has become aware of a potential set of circumstances that could cause x-ray continuation during an unexpected table stop on certain brightspeed systems (brightspeed excel/edge/elite select and brightspeed elite computed tomography x-ray systems ) if this event were to occur on your system, patient safety may be impacted.
  • 조치
    The firm, GE Healthcare, sent an "URGENT MEDICAL DEVICE CORRECTION GE Ref: 22932" letter dated January 19, 2011 to its consignees/customers. The letter described the Safety Issue, Affected Product Details, Safety Instructions, Product Correction, Contact Information, and Additional Dosimetric Information. A second letter dated March 11, 2011 was sent to the consignee/customer letter consisting of a cover letter and an attachment. "This letter is to notify you of an error in the January 19, 2011, Urgent Medical Device Correction Letter, that you have already received (GE Ref: 22932). In the Safety Issue section of that letter it is written: "If this issue were to occur, it would result in the remainder of the exposure being delivered at the patient position where the table stopped up to the prescribed scan time or 30 seconds, whichever is shorter." The stated 30 seconds limitation is incorrect for your particular model. This information has been corrected on the attached Urgent Medical Device Correction letter, so please discard the original letter if it is still in your possession. " GE Healthcare will provide a software update for all affected systems to address the issue. A GE Healthcare service representative will contact you to arrange for this correction. The customers were also instructed as follows: prior to GE's installation of a software update, continue to monitor patient scanning closely. Should the table stop unexpectedly and X-ray remains on, manually stop the scan, and ensure that all potential users in your facility are made aware of this safety notification and the recommended actions. If you have any questions, please contact GE immediately at the following: United States: 800-437-1171; Japan: 0120-055-919; Korea: 1544-6119; Australia/New Zealand: 800-659-465 and China: 800-810-8188. For other countries please contact your local GE Healthcare Service Representative if you have any questions or concerns regarding this notifi

Device

  • 모델명 / 제조번호(시리얼번호)
    SERIAL 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  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: USA (nationwide) including states: AL, CA, CO, CT, FL, GA, ID, IL, IN, IA, KS, KY, LA, MI, MN, MS, MO, NE, NH, NJ, NM, NY, NC, OH, PR, RI, SC, SD, TN, TX, and WV; and countries including: URUGUAY, TURKEY, SWITZERLAND, SWEDEN, SPAIN, SOUTH AFRICA, SAUDI ARABIA, RUSSIAN FEDERATION, ROMANIA, REUNION, PUERTO RICO, PORTUGAL, POLAND, PARAGUAY, NEW ZEALAND, NETHERLANDS, MEXICO, MARTINIQUE, LEBANON, JAPAN, ITALY, INDONESIA, INDIA, HUNGARY, GREECE, GERMANY, FRANCE, EGYPT, COLOMBIA, CHINA, CHILE, BRAZIL, BELGIUM, BELARUS, BAHRAIN, AUSTRALIA, ANGOLA, ALGERIA. TUNISIA, THAILAND, SYRIAN ARAB REPUBLIC, PHILIPPINES, PARAGUAY, OMAN, NEW ZEALAND, MOROCCO, KUWAIT, KAZAKHSTAN, ISLAMIC REPUBLIC OF IRAN, ARGENTINA.
  • 제품 설명
    BrightSpeed Excel Select, BrightSpeed Edge Select ,BrightSpeed Elite Select and BrightSpeed Elite Computed Tomography X-ray systems with software version 09BW35.11 or 09HW30.4. || The GE BrightSpeed Delight Series Computed Tomography X-ray system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes, for patients of all ages, including Axial, Cine, Helical, Cardiac, and Gated acquisitions. These images may be obtained either with or without contrast.
  • Manufacturer

Manufacturer

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