Philips Gel-E Donut and Squishon 2 (Gel filled Pillow) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Philips Electronics Australia Ltd 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
    RC-2014-RN-00773-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2014-07-18
  • 사례 국가
  • 사례 출처
    DHTGA
  • 사례 출처 URL
  • 비고 / 경고
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • 데이터 추가 비고
  • 원인
    Philips healthcare has received a number of complaints about visible mould on gel-e donut and squishon 2 gel-filled products. the mould manifests as small black markings on the outer surface of the gel-e donut and squishon pad, which are visible through the transparent outer packaging. the mould detected on the product has been cladosporium and penicillium fungi, which are commonly found moulds. nicu and picu patients are much more sensitive to moulds and there is potential for the mould to be transferred to these environments once the outer pack is opened.
  • 조치
    Users are advised to review their entire inventory of Gel-E Donut and Squishon 2 products and inspect each product for signs of visible mold. Mold should be readily seen as black dots or splotches through the transparent outer packaging. Please do not open the packaging to do the inspection. If unsure or if the inspection is inconclusive, please err on the side of caution and designate that product as containing mold. Dispose of any product containing mold per facility’s environmental guidelines and return unaffected product to their inventory. Customers are also referred to the Instructions for Use, in particular: Wipe all Gel product surfaces with an antibacterial agent and cover the Gel product with a disposable cover or soft cloth before patient use. This action has been closed-out on 17/08/2016.

Device

  • 모델명 / 제조번호(시리얼번호)
    Philips Gel-E Donut and Squishon 2 (Gel filled Pillow)Part numbers: 92025-A, 92025-B, 92025-C (Gel-E Donut) and 91033-2 (Squishon 2)ARTG number: 200647
  • Manufacturer

Manufacturer

  • 제조사 모회사 (2017)
  • Source
    DHTGA