Device Recall Pediatric DirectWired Disposable Defibrillation/Pacing Electrodes

  • 모델명 / 제조번호(시리얼번호)
    Lots: 30618-0771, 30702-0778, 40217-0776, 40407-0777, 40424-0772, 40704-0775
  • 의료기기 분류등급
  • 의료기기 등급
    3
  • 이식된 장치?
    No
  • 유통
    US Nationwide Distribution in the states of OH and TX.
  • 제품 설명
    GE Healthcare Pediatric Direct-Wired Disposable Defibrillation/Pacing Electrodes. REF 2059144-001 and 2059144-005. . || Product Usage: Usage: || Skintact Pediatric Multifunction Electrodes are for use on pediatric patients, less than 8 years of age, or weighing less than 25 kg (55 lbs), for external defibrillation, pacing, monitoring and cardioversion. The device is non-sterile and for single use only.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Leonhard Lang Gmbh, Archenweg 56, Innsbruck Austria
  • 제조사 모회사 (2017)
  • Source
    USFDA