Events

Rappel de Invacare Perfecto 2 V Oxygen Concentrator

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 Invacare Corporation.

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
    69441
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0577-2015
  • Date de publication de l'événement
    2014-12-12
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-06-18
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=130540
  • 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
    Generator, oxygen, portable - Product Code CAW
  • Cause
    It was determined that a defective sieve bed subassembly enabled zeolite sieve dust from the sieve beds to migrate into the valves of the manifold assembly and muffler causing a reduction in oxygen concentration.
  • Action
    Invacare sent an Urgent - Medical Device Recall letter to customers, dated October 2014. The letter identified the affected product as well as the problem involved. The letter instructed customers to examine their device and confirm that it has an affected serial number, or if service was conducted on the device using IRC5O2V Service Part Number 1165099 with the affected date codes. Customers were asked to immediately contact their dealer or service provider at the number listed, so that a replacement can provided. A service provider or dealer should be contacted with questions regarding the instructions.

Device

Invacare Perfecto 2 V Oxygen Concentrator
  • Modèle / numéro de série
    The defective sieve bed subassembly manufactured from 7/31/2014 to 8/19/2014 impacts the finished device- IRC5PO2V and Service Part Number-1165099.   The serial number range is as follows for the finished device:  14GF053772-14HF032124 (Sequential serial numbers)
  • Classification du dispositif
    Anesthesiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution -- FL, NJ, GA, RI, PA, MI, CA, MA, IN, WA, CT, VA, NC, MO, AZ, CO, MS, MI, WI, TN, NH, IL, LA, OK, HI, KY, NE, SC, TX, IA, IN, and MS.
  • Description du dispositif
    Invacare Perfecto 2 V Oxygen Concentrator || The finished device is packaged as a single unit. || The service part contains a single pair of sieve beds; one pair of sieve beds is used in a single finished device. || Intended to provide supplemental oxygen to patients with respiratory disorders, by separating nitrogen from room air, by way of a molecular sieve.
  • Manufacturer
    Invacare Corporation

Manufacturer

Invacare Corporation
  • Adresse du fabricant
    Invacare Corporation, 1200 Taylor St, Elyria OH 44035-6248
  • Société-mère du fabricant (2017)
    Invacare Corporation
  • Source
    USFDA