Events

Rappel de Device Recall Flexicair II

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 Hill-Rom Manufacturing, 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
    52032
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1874-2009
  • Date de mise en oeuvre de l'événement
    2009-05-12
  • Date de publication de l'événement
    2009-08-03
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-04-03
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=81938
  • 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
    air therapy mattress - Product Code IOQ
  • Cause
    The devices may emit smoke from the blower box assembly.
  • Action
    Urgent Field Safety Notice letter dated May 11, 2009. Hill-Rom service centers were notified by letter on 05/13/2009. Action to be taken are as follows: Rental Customers; In the next 60 days, Hill Rom will be removing the Flexicair¿ II and Flexicair¿ MC3 low Airloss Therapy Units from service to correct the devices. During that time, Hill-Rom may provide an equivalent substitute therapy to accommodate the patients who continue to need a pressure reducing therapy device. If t his malfunction occurs before a substitution or a corrected device is provided, unplug the device, remove the patient from the surface and notify Hill-Rom immediately. Facility-Owned Customers: In the next 60 days, for all facility owned Flexicair II and Flexicair¿ MC3 Low Airloss Therapy Units, a Hill-Rom service technician will either replace the affected components in the blower assembly or deliver an equivalent substitute unit from Hill-Rom's rental fleet. If this malfunction occurs before the device is corrected or a substitute provided, do as follows: unplug the device, remove the patient from the surface, and immediately notify Hill-Rom Technical Support using the attached listing their geographical region.

Device

Device Recall Flexicair II
  • Modèle / numéro de série
    All serial numbers. The devices have a nomenclature for each respective product model where the serial number is IBxxxxxx, where "xxxxxx" is a six digit number. The prefix "IB" is representative of a Flexicair¿ II.
  • Classification du dispositif
    Physical Medicine Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide and Canada
  • Description du dispositif
    Flexicair¿ II (model 13000) Low Airloss Therapy Units, for the prevention of pressure sores.
  • Manufacturer
    Hill-Rom Manufacturing, Inc.

Manufacturer

Hill-Rom Manufacturing, Inc.
  • Adresse du fabricant
    Hill-Rom Manufacturing, Inc., 4349 Corporate Rd, Charleston SC 29405-7445
  • Source
    USFDA