Device Recall LAP Surgical Transducer 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Sonosite, Inc. 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
    49387
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2654-2010
  • 사례 시작날짜
    2007-11-02
  • 사례 출판 날짜
    2010-10-01
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2010-10-05
  • 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
    Laparoscopic Ultrasound Transducer - Product Code IYN
  • 원인
    Sterilization of the sonosite lap surgical transducer with the sterrad nx system may result in damage to the transducer.
  • 조치
    On November 2, 2007, SonoSite sent out the Important Information Regarding Sterrad NX Incompatibility letter and the Technical Bulletin 005/07 Rev A to their consignees. The letter advises the consignees that SonoSite has recently found that sterilization of the SonoSite SLT and LAP surgical ultrasound transducers with the Sterrad NX system may result in damage to the transducer. The Technical Bulletin 005/07 Rev B dated November 2, 2007 informs the consignees that the damage has been observed primarily on the circuit board in the transducer connector, and cable and laparoscope damage may also be occurring. All damages have occurred after processing using the Sterrad NX systems in its "Advanced" cycle and the potential damage from the use of "normal" cycle is being evaluated by the firm. Consignees should call the Technical Support at 1-425-951-1330 or 1-877-657-8118 or e-mail to service@sonosite.com for any questions regarding the recall.

Device

  • 모델명 / 제조번호(시리얼번호)
    16 devices are identified with Serial Numbers:  038VWM, 038FK1, 0379P6, 038G67, 038VWK, 038192, 0379P1, 0379P2, 038FJZ, 038FJW, 0379P0, 0379P5, 037WMJ, 038VWP, 037XT6, and 038153.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Devices were distributed to medical centers and hospitals in AR, CA, IN, KS, MA, MD, MI, NC, NE, NJ, NV, OH, SC, TN, TX, WI, Washington DC and to FOREIGN COUNTRIES Australia, China, France, Germany, Greece, Hong Kong, India, Iraq, Italy, Korea, Republic of, Libyan Arab Jamahiriya, Mexico, Spain, United Arab Emirates, United Kingdom, and United States.
  • 제품 설명
    Laparoscopic Ultrasound Transducer (LAP Transducer) is used on the SonoSite MicroMaxx ultrasound system. The LAP Transducer label is labeled in part: "MicroMaxx LAP...Manufactured for SonoSite, Inc., Bothell, WA 98021".
  • Manufacturer

Manufacturer

  • 제조사 주소
    Sonosite, Inc., 21919 30th Dr Se, Bothell WA 98021-3904
  • Source
    USFDA