Events

Rappel de AmeriWater MRO Dialysis RO System

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 AmeriWater 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
    62891
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2321-2012
  • Date de mise en oeuvre de l'événement
    2012-08-09
  • Date de publication de l'événement
    2012-09-06
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-04-17
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=111946
  • 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
    Subsystem, water purification - Product Code FIP
  • Cause
    The firm was notified that a malfunction of the device was caused by an incorrect fuse 32 volt 15 amp fuses instead of 250 volt 15 amp fuses, that was installed in the water system. the incorrect fuse may result in excessive heat in the fuse holder eventually resulting in failure of the device to operate.
  • Action
    The firm, AmeriWater, sent an "URGENT: MEDICAL DEVICE RECALL" letter dated August 9, 2012, to its customers. The letter describes the product, problem and actions to be taken. The customers were instructed to immediately examine their inventory and quarantine the product subject to recall; remove affected devices from service until the correction is completed to prevent malfunction of the device during patient treatment; and complete and return the attached response form to AmeriWater within 30 days via fax to 937/461-1988 Attn: Quality Assurance. AmeriWater dealer will be contacting their customers to schedule replacement of the fuses. If you have any questions, contact your local AmeriWater dealer or AmeriWater customer service at 1-800-535-5585.

Device

AmeriWater MRO Dialysis RO System
  • Modèle / numéro de série
    Model Number MROS, Catalog #00MROS20, 00MROS21 & Model Number MRO1, Catalog #00MRO120, and 00MRO121; Model Number(s): MROS and MRO1; Serial #'s 31000 to 31079.
  • Classification du dispositif
    Gastroenterology-Urology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution: USA (nationwide) including states of: AL, AR, CO, CT, FL, GA, IL, IN, KS, MA, MD, MO, MS, NC, NY, OH, OK, SC, TN, TX and VA; and country of: Canada.
  • Description du dispositif
    AmeriWater MRO Dialysis RO+ System, AmeriWater 1303 Stanley Avenue, Dayton, OH 45404 (800) 535-5585 www.AMERIWATER.com. || The AmeriWater MRO Portable Reverse Osmosis Systems are water treatment systems intended for use in hemodialysis applications. They are designed to pre-treat and purify potable water for use in making dialysate for hemodialysis and to meet current AAMI and Federal (U.S.) standards. The AmeriWater Portable MROS model is intended for use in a hospital, clinic, dialysis center, or for home care for single patient use. The AmeriWater Portable MRO1 model is for treatment of up to two patients in a hospital, clinic, or dialysis centers.
  • Manufacturer
    AmeriWater Inc

Manufacturer

AmeriWater Inc
  • Adresse du fabricant
    AmeriWater Inc, 1303 Stanley Ave, Dayton OH 45404-1015
  • Source
    USFDA