Events

Rappel de Device Recall Clinitron At Home Air Fluidized Therapy Unit

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
    27190
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0057-04
  • Date de mise en oeuvre de l'événement
    2002-01-14
  • Date de publication de l'événement
    2003-10-24
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2003-10-27
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=29401
  • 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, Air Fluidized - Product Code INX
  • Cause
    Power cord overheating.
  • Action
    Consignees were notified by letter sent January 14, 2002 warning them of the hazard involved with the defective part. They were informed that Hill Rom needed to replace the power cord on each unit to correct the possibility of the power cord from overheating, melting or smoking. The maintenance would be performed at the location of each unit (most of which are at their rental facilities located nationwide) by the firm''s servicing representatives. Meanwhile, customers were urged to check the power cord to ensure that it is fully inserted into the wall outlet and the connector on the Clinitron At Home Air Fluidized Therapy Unit. The modification was to be completed by August 31, 2002.

Device

Device Recall Clinitron At Home Air Fluidized Therapy Unit
  • Modèle / numéro de série
    Model 206 (CS), Serial numbers 101671 and 103443 510K: K942184
  • Classification du dispositif
    Physical Medicine Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Hill Rom primarily leases these units to home care patients and some are sold nationwide.
  • Description du dispositif
    Clinitron At Home¿ Air Fluidized Therapy Unit
  • Manufacturer
    Hill-Rom Manufacturing, Inc.

Manufacturer

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