Events

Rappel de Patriot Full Electric Homecare Beds, Patriot LX Full Electric Homecare Beds

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par GF Health Products, Inc.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    75460
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0732-2017
  • Statut de l'événement
    Open, Classified
  • Pays de l'événement
    United States
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=150433
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Bed, ac-powered adjustable hospital - Product Code FNL
  • Cause
    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.
  • Action
    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
  • Modèle / numéro de série
    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
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA ( nationwide) Distribution including Puerto Rico and to the countries of : Bahamas, Canada, Chile, El Salvador and Santo Domingo.
  • Description du dispositif
    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
  • Adresse du fabricant
    GF Health Products, Inc, 336 Trowbridge Dr, Fond Du Lac WI 54937-9103
  • Société-mère du fabricant (2017)
    GF Health Products Inc.
  • Source
    USFDA