Events

Device Recall Sonopet Ultrasonic Aspirator Console 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Stryker Instruments Div. of Stryker Corporation 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
    65486
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1879-2013
  • 사례 시작날짜
    2013-06-24
  • 사례 출판 날짜
    2013-08-06
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2014-01-30
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=119857
  • 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
    Instrument, ultrasonic surgical - Product Code LFL
  • 원인
    A supplied component exhibiting corrosion was built into the power supply boards of the sonopet consoles listed above. the issue is limited to 2 lots of the supplied component. the presence of the corrosion on the relay of the power supply board can potentially lead to a conduction defect which could cause the irrigation pump to stop working. the purpose of the irrigation pump is to supply sali.
  • 조치
    Stryker sent an URGENT Medical Device Recall Notice letter dated June 24, 2013 to all affected customers. The letter identified the affected product, product issue, risk to health and actions to be taken. Customers were instructed to locate affected product and hold for upgrade, use enclosed response form to document inventory and receipt of notice, and in case of further distribution forward the recall notice. Stryker will dispatch a technician to perform the upgrade to the affected product. For questions regarding this recall please contact Stryker Instruments: Monday-Friday 8am-5pm (EST) Kara Spath, Regulatory Affairs 269-389-4518 kara.spath@stryker.com.

Device

Device Recall Sonopet Ultrasonic Aspirator Console
  • 모델명 / 제조번호(시리얼번호)
    5450-851-000(Console 100V) S/N 1127900134, 1133400114, 1202400224, 1205800094, 1226800284, 1127900144, 1133400124, 1202400234, 1205800104, 1226800294, 1127900154, 1133400134, 1202400244, 1206200574, 1226800304, 1127900164, 1133400144, 1203700594, 1206200584, 1228500194, 1127900174, 1133400154, 1203700604, 1206200594, 1228500204, 1127900184, 1133900014, 1205100514, 1222800034, 1228500214, 1127900194, 1133900024, 1205100524, 1222800044, 01J0018, 1127900204, 1133900034, 1205100534, 1224800314, 02B0052, 1130500054, 1133900044, 1205100544, 1225500084, 02G0091, 1130500064, 1133900054, 1205100554, 1225500094, 05H0386, 1130500074, 1201300384, 1205100564, 1225500104, 1130500084, 1202400154, 1205100574, 1225500114, 1130800374, 1202400164, 1205100584, 1225500124, 1130800384, 1202400174, 1205100594, 1226800234, 1130800394, 1202400184, 1205100604, 1226800244, 1130800404, 1202400194, 1205800064, 1226800254, 1130800414, 1202400204, 1205800074, 1226800264, 1130800424, 1202400214, 1205800084, 1226800274.
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    Unclassified
  • 이식된 장치?
    No
  • 유통
    Worldwide - USA Nationwide including the states of CA, CO, FL, HI, IA, IL, KS, KY, LA, MD, MI, MN, MS, NC, NH, NJ, NV, NY, OH, PA, TX, VA, ITALY, and the countries of AUSTRALIA, CANADA, UNITED KINGDOM, NETHERLANDS, INDIA, JAPAN, NEW ZEALAND, SWITZERLAND, HONG KONG, and TAIWAN.
  • 제품 설명
    Sonopet Ultrasonic Aspirator Console || 5450-851-000(Console 100V) || Product Usage: || The Sonopet Console is indicated for use in surgical procedures where fragmentation, emulsification, and aspiration of soft and hard tissue is desirable, including neurosurgery, gastrointestinal and affiliated organ surgery, urological surgery, plastic and reconstructive surgery, general surgery, orthopedic surgery, gynecological surgery, thoracic surgery, laparoscopic surgery, and thoracoscopic surgery.
  • Manufacturer
    Stryker Instruments Div. of Stryker Corporation

Manufacturer

Stryker Instruments Div. of Stryker Corporation
  • 제조사 주소
    Stryker Instruments Div. of Stryker Corporation, 4100 E Milham Ave, Portage MI 49002-9704
  • 제조사 모회사 (2017)
    Stryker
  • Source
    USFDA