Device Recall External Sterilizable Paddles

  • 모델명 / 제조번호(시리얼번호)
    The product does not have serial numbers or lot numbers.   External Sterilizable Paddles used with LIFEPAK 12 and 20/20e Defibrillators have a Part Number 3009166-XX (XX symbolized any 2 numbers).   External Sterilizable Paddles used with LIFEPAK 9 and 9P Defibrillators have a Part Number 804507-XX (XX symbolizes any 2 numbers).
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Devices were distributed to medical facilities through out the US and WORLD WIDE to Canada, Germany, India, Netherlands, Australia, Hong Kong, Japan, Brazil, Panama, Russia, Korea, Malaysia, Venezuela, and United Arab Emirates(UAE) .
  • 제품 설명
    External Sterilizable Paddles for use with the LIFEPAK 9, LIFEPAK 9P, LIFEPAK 12, and LIFEPAK 20/20e Defibrillator/Monitor.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Physio Control, Inc., 11811 Willows Rd Ne, Redmond WA 98052-2003
  • 제조사 모회사 (2017)
  • Source
    USFDA