Events

Device Recall VENTAK PRIZM 2 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Boston Scientific CRM Corp 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
    35754
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1297-06
  • 사례 시작날짜
    2006-06-24
  • 사례 출판 날짜
    2006-09-28
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2008-03-02
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=46734
  • 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
    Defibrillator - Product Code KRG
  • 원인
    Guidant has determined that low-voltage capacitors from a single component supplier may malfunction in a manner that can lead to premature battery depletion in the affected devices.
  • 조치
    A Press Release was issued on 06/26/06. An Urgent Medical Device Safety Information & Corrective Action letter, dated 06/23/06 was delivered to physicians describing preliminary information before Guidant has completed its own investigation and finalized patient care recommendations. Non-implanted inventory is being retrieved from hospital shelves and Guidant Represenatatives. Physicians are to perform an in-clinic follow-up exam as soon as possible with patients implanted with affected devices.

Device

Device Recall VENTAK PRIZM 2
  • 모델명 / 제조번호(시리얼번호)
    model 1860, serial numbers: 144889, 144891, 144893 thru 144903, 144926, 144927, 144930, 144932, 144942, 144946, 144947, 144950, 144955 thru 144957, 144959, 144965 thru 144979, 144981, 144983, 144985 thru 144989, 144991, 144994, 145000 thru 145005, 145009, 145012, 145013, 145015 thru 145028, 145030 thru 145044, 145050 thru 145053, 145055, 145056, 145058 thru 145061, 145065 thru 145069, 145071 thru 145078.   model 1861, serial numbers: 266473, 266475, 266477, 266478, 266480 thru 266483, 266485, 266487, 266488, 266492 thru 266494, 266496 thru 266506, 266510, 266511, 266516, 266518 thru 266521, 266523, 266525 thru 266527, 266532, 266533, 266535, 266536, 266553 thru 266557, 266561, 266576 thru 266578, 266580, 266582 thru 266587, 266608, 266617, 266632, 266637, 266641, 266663, 266665, 266668, 266671, 266676, 266684, 266685, 266694 thru 266696, 266699, 266702, 266705 thru 266712, 266714 thru 266728, 266732 thru 266741, 266744 thru 266749, 266753, 266764, 266769 thru 266775, 266777, 266779, 266780, 266782, 266784, 266786 thru 266794, 266796 thru 266798, 266802, 266803, 266805, 266807, 266812, 266820, 266823, 266824, 266829, 266832, 266833, 266835 thru 266837, 266839, 266841 thru 266843, 266849 thru 266857, 266859 thru 266863.
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    No
  • 유통
    Worldwide- USA and Antigua Barbuda, Argentina, Australia, Austria, Belgium, Canada, Chile, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, Germany, Greece, Guadeloupe, Guam, Hong Kong, Iceland, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kenya, Korea, Kuwait, Lebanon, Luxembourg, Malaysia, Mexico, Micronesia, Netherlands, Netherlands Antilles, New Zealand, Norway, Panama, Peru, Philippines, Polynesia, Portugal, Qatar, Reunion, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Swaziland, Sweden, Switzerland, Syrian Arab Republic, Taiwan R O C, Thailand, Tunisia, Turkey, United Kingdom, Uruguay, Venezuela
  • 제품 설명
    Guidant VENTAK PRIZM VR (model 1860) and VENTAK PRIZM DR (model 1861) Automatic Implantable Cardioverter Defibrillator (AICD), Dual Chamber, Sterilized with gaseous ethylene oxide. Guidant Corporation, Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Quantities Distributed by model are as follows: VENTAK PRIZM VR model 1860 = 67; DR model 1861 = 108.
  • Manufacturer
    Boston Scientific CRM Corp

Manufacturer

Boston Scientific CRM Corp
  • 제조사 주소
    Boston Scientific CRM Corp, 4100 Hamline Ave N, Saint Paul MN 55112-5700
  • Source
    USFDA