Events

Philips Heartstart HS1 OnSite 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Philips Medical Systems 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
    55579
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1916-2010
  • 사례 시작날짜
    2010-04-30
  • 사례 출판 날짜
    2010-06-28
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-12-10
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=91631
  • 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
    Automated External Defibrillator - Product Code MKJ
  • 원인
    Seventeen aeds failed production line testing (final acceptance test).
  • 조치
    The firm notified U.S. distributors on 4/30/2010 via phone call and e-mail to obtain consignee location information. A website providing information was activated on 4/30/2010. On 5/3/2010 Urgent Medical Device Recall letters, dated April 29, 2010 were sent to direct customers in the US. The letters explained the reason for the recall and Customers were asked to verify that they have the product subject to recall. Replacement AEDs will be provided at no charge to the customer. Field Safety Notices were attached to the letters and provided a list of actions for customers to take. Customers should check the serial number on their devices against the list provided, contact Philips Healthcare to arrange for replacement, and ensure that necessary staff are aware of the recall. For further information and support, Philips Healthcare should be contacted at 1-800-263-3342.

Device

Philips Heartstart HS1 OnSite
  • 모델명 / 제조번호(시리얼번호)
    SERIAL NUMBERS--MODEL M5066A:  A10C-04048, A10C-04050, A10C-04300, A10C-04301, A10C-04302, A10C-04315, A10C-04316, A10C-04317, A10C-04318, A10C-04319, A10C-04320, A10C-04321, A10C-04322, A10C-04324, A10C-04325, A10C-04326, A10C-04327, A10C-04328, A10C-04330, A10C-04332, A10C-04333, A10C-04334, A10C-04335, A10C-04337, A10C-04338, A10C-04339, A10C-04340, A10C-04351, A10C-04352, A10C-04353, A10C-04354, A10C-04356, A10C-04357, A10C-04358, A10C-04359, A10C-04360, A10C-04361, A10C-04363, A10C-04364, A10C-04365, A10C-04366, A10C-04367, A10C-04368, A10C-04369, A10C-04611, A10C-04763, A10C-04812, A10C-04824, A10C-04824, A10C-05077, A10C-05078, A10C-05079, A10C-05080, A10C-05081, A10C-05083, A10C-05086, A10C-05087, A10C-05088, A10C-05089, A10C-05098, A10C-05151, A10C-05185, A10C-05191, A10C-05206, A10C-05207, A10C-05211, A10C-05212, A10C-05215, A10C-05216, A10C-05219, A10C-05233, A10C-05314, A10C-05315, A10C-05324, A10C-05397, A10C-05398, A10C-05429, A10C-05554, A10C-05569, A10C-05570, A10C-05571, A10C-05575, A10C-05578, A10C-05579, A10C-05580, A10C-05581, A10C-05583, A10C-05584, A10C-05585, A10C-05586, A10C-05587, A10C-05588, A10C-05591, A10C-05592, A10C-05593, A10C-05594, A10C-05595, A10C-05597, A10C-05599, A10C-05600, A10C-05751, A10C-05752, A10C-05759, A10C-05763, A10C-05764, A10C-05765, A10C-05767, A10C-05768, A10C-05769, A10C-05770, A10C-05771, A10C-05772, A10C-05775, A10C-05776, A10C-05777, A10C-05778, A10C-05779, A10C-05780, A10C-05781, A10C-05784, A10C-05785, A10C-05786, A10C-05787, A10C-05788, A10C-05789, A10C-05791, A10C-05792, A10C-05800, A10C-05913, A10C-05941, A10C-05968, A10C-05969, A10C-05970, A10C-05976, A10C-05977, A10C-05982, A10C-05983, A10C-06001, A10C-06002, A10C-06003, A10C-06006, A10C-06011, A10C-06013, A10C-06018, A10C-06020, A10C-06026, A10C-06027, A10C-06028, A10C-06354, A10C-06355, A10C-06356, A10C-06357, A10C-06358, A10C-06359, A10C-06360, A10C-06361, A10C-06364, A10C-06365, A10C-06366, A10C-06367, A10C-06368, A10C-06369, A10C-06370, A10C-06371, A10C-06372, A10C-06373, A10C-06374, A10C-06375, A10C-06376, A10C-06377, A10C-06378, A10C-06379, A10C-06381, A10C-06382, A10C-06383, A10C-06384, A10C-06385, A10C-06386, A10C-06387, A10C-06388, A10C-06390, A10C-06391, A10C-06392, A10C-06393, A10C-06394, A10C-06395, A10C-06396, A10C-06399, A10C-06400, A10C-06401, A10C-06402, A10C-06403, A10C-06404, A10C-06405, A10C-06406, A10C-06407, A10C-06408, A10C-06410, A10C-06411, A10C-06417, A10C-06418, A10C-06419, A10C-06420, A10C-06421, and A10C-06423.
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- USA, Canada, Japan, United Arab Emirates, Austria, Switzerland, Germany, Spain, France, Italy, and Norway.
  • 제품 설명
    Automated External Defibrillator(AED) of brand name "Philips HeartStart HS1 OnSite" (Model number M5066A). || Device is designed for use on a person in sudden cardiac arrest who is unresponsive when shaken and not breathing normally
  • Manufacturer
    Philips Medical Systems

Manufacturer

Philips Medical Systems
  • 제조사 주소
    Philips Medical Systems, 2301 5th Ave Ste 200, Seattle WA 98121
  • Source
    USFDA