Events

Patriot Full Electric Homecare Beds, Patriot LX Full Electric Homecare Beds 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 GF Health Products, 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
    75460
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0732-2017
  • 사례 상황
    Open, Classified
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=150433
  • 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, ac-powered adjustable hospital - Product Code FNL
  • 원인
    Gf health products, inc., in conjunction with okin america, has initiated a voluntary field correction affecting the okin america "duomat 3" head/foot motor used in the manufacture of our lumex patriot full electric bed model us0458/us0468 and patriot lx full electric bed model us6000. the failure mode is directly related to contaminated material in the plastic housing used to produce the duomat 3 motor. contaminated motor housings may crack resulting in a motor that will no longer actuate the head section per the intended design. if the head section were to fall it is unlikely but possible an injury could occur. no injuries have been reported.
  • 조치
    Graham Field sent an "Urgent Correction" letter dated September 30, 2016. The letter described the problem and the product involved in the recall. The letter described the " Action Required: Motor Replacement" . Informed consignees to contact GF Health Products at 1-888-974-4347 or fieldcorrection@grahamfield.com within ten (10) business days from receipt of this notification to schedule motor replacement order. Requested consignees to return the completed Certification of Replacement and Return Agreement to: fieldcorrection@grahamfield.com or Fax: 1-920-929-8213. For additional information, please call 1-888-974-4347; or at fieldcorrection@grahamfield.com.

Device

Patriot Full Electric Homecare Beds, Patriot LX Full Electric Homecare Beds
  • 모델명 / 제조번호(시리얼번호)
    BED SERIAL NUMBER RANGE US0458 / US0468 Patriot Full Electric 120V 697142145108 through 697142147927 US0458 / US0468 Patriot Full Electric 220V 697144140132 through 697144140172 US6000 Patriot LX Full Electric 120V 69204141262 through 69204141737   SERVICE MOTOR KITS WITH SHIP DATES OF MAY 4, 2015 THROUGH JUNE 30, 2016 Description Part Number Motor and Pendant Patriot Full Electric 120V 690-3001-943 / 690-7001-943 Boxed Full Electric 220V Motor 690-3220-943 Motor and Pendant Patriot LX Full Electric 120V 690-8004-912
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA ( nationwide) Distribution including Puerto Rico and to the countries of : Bahamas, Canada, Chile, El Salvador and Santo Domingo.
  • 제품 설명
    Lumex, Patriot Full Electric Homecare Bed, & Patriot LX Full Electric Homecare Bed containing the Okin Dumat 3 Head/Foot Motors. || Description Part Number || Motor and Pendant Patriot Full Electric 120V 690-3001-943 / 690-7001-943 || Boxed Full Electric 220V Motor 690-3220-943 || Motor and Pendant Patriot LX Full Electric 120V 690-8004-912
  • Manufacturer
    GF Health Products, Inc

Manufacturer

GF Health Products, Inc
  • 제조사 주소
    GF Health Products, Inc, 336 Trowbridge Dr, Fond Du Lac WI 54937-9103
  • 제조사 모회사 (2017)
    GF Health Products Inc.
  • Source
    USFDA