Device Recall ProCair Mattress 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Joerns Healthcare 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
    80113
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2034-2018
  • 사례 시작날짜
    2018-05-03
  • 사례 상황
    Open, Classified
  • 사례 국가
  • 사례 출처
    USFDA
  • 사례 출처 URL
  • 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
    Mattress, flotation therapy, non-powered - Product Code IKY
  • 원인
    Joerns healthcare has identified a potential issue with some of the p.R.O. matt and procair mattresses. for the identified serial number range of p.R.O. matt and procair mattresses incorrect connectors (part #s 206-0401 & 206-0405) were provided by a joerns supplier without the required internal shutoff valves, these shutoff valves prevent air from escaping from the mattress air cells.
  • 조치
    The firm initiated the recall by letter on 05/04/2018. The letter requested the consignee identify potentially affected mattresses and contact Joerns Healthcare directly to schedule on-site rework of the unit. Distributors were directed to provide the recall information to their accounts.

Device

  • 모델명 / 제조번호(시리얼번호)
    (a) PROCAIR PLUS 42X80, MATERIAL NUMBER 222-4280 Serial Numbers: 1000054866 1000054860 1000051368 1000054859 1000054855 1000054857  (b) PROCAIR PLUS 36X80, MATERIAL NUMBER 222-3680 Serial Numbers: 1000053319 1000053312 1000052886 1000053325 1000053323 1000052420 1000052259 1000052426 1000052425 1000052432 1000052891 1000052458 1000052429 1000052256 1000052888 1000053990 1000051418 1000051419 1000052457 1000052252 1000051411 1000055556 1000052460 1000054129 1000053979 1000049129 1000051412 1000052424 1000052455 1000054117 1000053982 1000053983 1000054122 1000054121  (c) PROCAIR PLUS 84" MATTRESS, MATERIAL NUMBER 222-6384 Serial Numbers: 1000055501 1000049132 1000055498 1000057147 1000055500 1000056219
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US Nationwide in the states of UK, Canada, Holland
  • 제품 설명
    ProCair Mattress: || (a) PROCAIR PLUS 42X80, MATERIAL NUMBER 222-4280 || (b) PROCAIR PLUS 36X80, MATERIAL NUMBER 222-3680 || (c) PROCAIR PLUS 84" MATTRESS, MATERIAL NUMBER 222-6384 || Product Usage: || Non powered flotation therapy mattress. The device is intended to treat or prevent decubitus ulcers (bed sores).
  • Manufacturer

Manufacturer

  • 제조사 주소
    Joerns Healthcare, 2100 Design Rd, Arlington TX 76014-4593
  • Source
    USFDA