Device Recall AED 10

  • 모델명 / 제조번호(시리얼번호)
    Software version 2.02 or lower. The ECG analysis/noise issue involves all units manufactured before January 2006 when a design/component change was made.
  • 의료기기 분류등급
  • 의료기기 등급
    3
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution.
  • 제품 설명
    Welch Allyn AED 10 automated external defibrillator and MRL Jumpstart (collectively "AED 10")
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Welch Allyn Protocol, Inc, 8500 Sw Creekside Pl, Beaverton OR 97008
  • 제조사 모회사 (2017)
  • Source
    USFDA

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 2 건

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  • 모델명 / 제조번호(시리얼번호)
    Affected serial numbers are listed on http://www.welchallyn.com/AED10Recall
  • 의료기기 분류등급
  • 의료기기 등급
    3
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution.
  • 제품 설명
    Welch Allyn AED 10 automated external defibrillator and MRL Jumpstart (collectively "AED 10")
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Blown fuse serial numbers: 008577 - 013143 inclusive. Voice prompt serial numbers: 002002 - 008286 inclusive, and 008289 008291 008293 008296 008297 008298 008299 008300 008301 008302 008303 008304 008305 008306 008307 008308 008309 008310 008311 008312 008313 008314 008315 008316 008322 008323 008324 008325 008326 008327 008328 008329 008330 008331 008332 008333 008334 008335 008336 008337 008339 008340 008362 008363 008364 008365 008366 008367 008368 008369 008370 008372 008373 008374 008375 008376 008377 008378 008379 008402 008403 008404 008405 008406 008407 008411 008413 008414 008415 008416 008417 008418 008419 008420 008421 008422 008423 008424 008425 008426 008427 008428 008429 008430 008431 008432 008435 008446 008524 008525 008583 008656 008671 008712 008714 008724 008742 008743 008744 008792 008856 008864 008911 008913 008943 008988 009007 009009 009010 009015 009016 009017 009066 009067 009070 009071 009072 009073 009074 009075 009076 009079 009081 009083 009085 009086 009087 009122 009123 009124 009126 009127 009128 009129 009130 009139 009715 009813 010108 010168 012603 013659 013665 013727 016604 019508 020910 020911 020912 022356  and 027224.
  • 의료기기 분류등급
  • 의료기기 등급
    3
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution.
  • 제품 설명
    Welch Allyn AED 10 automated external defibrillator and MRL Jumpstart (collectively "AED 10")
  • Manufacturer