Events

Device Recall ACUSON SC2000 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Siemens Medical Solutions USA, 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
    75639
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0667-2017
  • 사례 시작날짜
    2016-11-07
  • 사례 출판 날짜
    2016-11-28
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-05-26
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=150975
  • 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, imaging, pulsed doppler, ultrasonic - Product Code IYN
  • 원인
    Firm received reports about "acquisition errors" and the deterioration of material covering the articulating section of the z6ms transesophageal transducer.
  • 조치
    Siemens sent a Customer Safety Advisory Notification letter to all affected customers on November 7, 2016 by certified mail advising them of the issue and identified steps that can be taken to avoid potential risk of this issue. This letter has been released first in English while translations are being completed. Once the translations are complete customers in the countries who require translations will receive the letter. Prior to this mailing, ECO #641310 was released on July 5, 2016 and implemented into forward production on July 28, 2016 (SN 63028009) to correct the susceptibility to Gastro-flex circuit corrosion and electro migration. The ECO changed standard copper traces and traditionally applied solder mask on the circuit to fully gold plated traces with a dry film solder mask. ECO #645821 was released on September 8, 2016 date and implemented into forward production on September 8, 2016 (SN 63530013) to correct susceptibility to articulation sleeve damage. The ECO changed the articulation sleeve material from C-Flex to Viton. For questions regarding this recall call 650-694-5398.

Device

Device Recall ACUSON SC2000
  • 모델명 / 제조번호(시리얼번호)
    Model number 10436113 -Z6Ms Transesophageal tranducer. US Serial numbers: 63229007 63229008 63432010 63530518 63322007 63230009 63260584 63530516 63432007 63319012 63332004 63325007 63328003 63328007 63332002 63029015 63329017 63230003. Foreign serial numbers: 63260585 63230002 63029009 63329018 63229011 63432015 63229012 63430524 63029016 63360611 63360612 63432017.
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US (nationwide) Internationally to AUSTRIA, GERMANY, SOUTH AFRICA, NETHERLANDS, MAURITIUS, MEXICO, and ITALY, JAPAN, SWEDEN
  • 제품 설명
    Z6Ms transesophageal transducers used on ACUSON SC2000 ultrasound systems, Z6Ms model 10436113. || Radiology: || The ACUSON SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transesophageal, Adult Cephalic, Peripheral Vessel, Abdominal, Abdominal Intraoperative, Intraoperative Neurological, Neurological-skeletal Conventional, and Musculo-skeletal Superficial applications. The system || also provides the ability to measure anatomical structures and calculation packages that provide information to the clinician that may be used adjunctive with other medical data obtained by a physician for clinical diagnosis purposes.
  • Manufacturer
    Siemens Medical Solutions USA, Inc.

Manufacturer

Siemens Medical Solutions USA, Inc.
  • 제조사 주소
    Siemens Medical Solutions USA, Inc., 685 E Middlefield Rd, Mountain View CA 94043-4045
  • 제조사 모회사 (2017)
    Siemens Ag
  • Source
    USFDA