Events

Device Recall Viasys Healthcare, Sonora Transcranial Doppler (TCD) System 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Cardinal Health, 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
    50875
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0998-2009
  • 사례 시작날짜
    2009-01-06
  • 사례 출판 날짜
    2009-04-07
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-07-03
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=77578
  • 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
    Internal testing has identified several several scenarios where unexpected system lockups, shutdowns or system errors would render the sonara unavailable for use until the sonara can be restarted. these issues can be corrected by installing the version 6.0 b045 software updating the audio driver and updating to xp service pack 3. additionally, improper wiring could cause the cooling fan to not op.
  • 조치
    Consignees were sent a Cardinal Health "Urgent: Medical Device Correction" letter dated January 12, 2009 beginning the week of February 2, 2009 and continuing into week of February 9, 2009. The letter was addressed to customers describing the problems and systems affected and solutions. Cardinal Health requested customers to complete the actions listed in the letter to install the Field Correction and return the completed "Verification Form" via mail, e-mail or fax to Cardinal Health-NeuroCare. Further information can be obtained by calling 1-800-356-0007 ext 2191 or fax to 1-877-244-3805.

Device

Device Recall Viasys Healthcare, Sonora Transcranial Doppler (TCD) System
  • 모델명 / 제조번호(시리얼번호)
    Serial Numbers:  PWH0297 PWH0212 PWH0221 PWH0309 PWH0246 PWH0250 PWH0223 PWH0429 PWH0245 PWH0292 PWH0298 PWH0214 PWH0211 PWH0210 PWH0219 PWH0216 PWH0224 PWH0215 PWH0213 PWH0220 PWH0253 PWH0252 PWH0254 PWH0221 PWH0218 PWH0217 06-2506 06-2504 05-2506 PWH0251 06-2501 06-2500 06-2503 06-2502 05-2502 and 05-2500.
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- USA including states of FL, DC, LA, NJ, NY, PA, TN, TX, WI, CA, MO, and LA and countries including THAILAND, SINGAPORE, SERBIA-MONTENEGRO, PORTUGAL, PHILIPPINES, POLAND, NORWAY, NETHERLANDS, KOREA, ITALY, ISRAEL, HUNGARY, HONG KONG, GREAT BRITAIN, SPAIN, GERMANY, CZECH REPUBLIC, SWITZERLAND, CANADA, BULGARIA, and BOSNIA-HERZEGOVINA.
  • 제품 설명
    Viasys Healthcare, Sonora Transcranial Doppler (TCD) System. Model Sonara. Part Number of Units: 982A0469 Sonara Unilateral. || The Sonara Transcranial Doppler system is a medical ultrasound device for noninvasively measuring the blood flow velocities in arteries and veins.
  • Manufacturer
    Cardinal Health, Inc

Manufacturer

Cardinal Health, Inc
  • 제조사 주소
    Cardinal Health, Inc, 5225 Verona Rd, Madison WI 53711-4497
  • 제조사 모회사 (2017)
    Cardinal Health
  • Source
    USFDA