Events

XPRT Therapy Mattress Systems 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Gaymar Industries Inc 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
    30065
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0260-05
  • 사례 시작날짜
    2004-10-25
  • 사례 출판 날짜
    2004-11-30
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2006-02-08
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=35105
  • 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
    Bed, Patient Rotation, Powered - Product Code IKZ
  • 원인
    Design control/validation deficiencies.
  • 조치
    Letter dated 10/25/2004 to Stryker Medical, own-label distributor, with instructions to remove patients from the system and return units to Gaymar.

Device

XPRT Therapy Mattress Systems
  • 모델명 / 제조번호(시리얼번호)
    The following serial numbers, which represent all units shipped: H40001 thru H40038; and I40001, I40003, I40004, I40005, I40006, I40009, I40012, I40013, I40014, I40017, I40018, and I40021.
  • 의료기기 분류등급
    Physical Medicine Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    The units were sold to the own-label distributor, who in turn sold 8 units to two hospitals in Nebraska and Hawaii.
  • 제품 설명
    XPRT Therapy Mattress Systems: || Model # 2950-000-000 with Dartex urethane-coated nylon cover (deluxe cover); and Model # 2950-000-001 with nylon cover without coating (standard cover). || Responsible firm on the label: Manufactured for STRYKER MEDICAL, 6300 South Sprinkle Road, Kalamazoo, MI USA 49001-9799, 1-800-327-0770. || The unit consists of a sleep surface, an integrated valve box located in the head of the mattress, a pump box located under the foot of the mattress and a color touch screen controller that can be mounted to either side of the pump box at the foot end of the mattress.
  • Manufacturer
    Gaymar Industries Inc

Manufacturer

Gaymar Industries Inc
  • 제조사 주소
    Gaymar Industries Inc, 10 Centre Dr, Orchard Park NY 14127-2280
  • Source
    USFDA