Events

Rappel de Device Recall ILED Surgical Light

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 Trumpf Medical Systems, 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
    51236
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1122-2009
  • Date de mise en oeuvre de l'événement
    2009-02-27
  • Date de publication de l'événement
    2009-04-01
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2009-10-22
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=79361
  • 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
    Ceiling Mounted Surgical Light - Product Code FSY
  • Cause
    Cracks may form around the screw connections of the cover plates causing brittleness, which may lead to fragments breaking off and falling into the operating area.
  • Action
    Consignees were notified via an Urgent Safety Information letter starting 02/27/2009. The Recall Notice asks customers to visually inspect the ILED covers for cracks and in particular to focus on the corners. If cracking is visible they are asked to remedy by taping with a clear tape over the cracks and report it to TRUMPF Medical Systems, Inc. immediately. TRUMPF will be replacing all covers with a newly designed and tested cover. Original priority in the United States will be set to start with the oldest units affected. If TRUMPF receives notification that cracking does exist then that facility will rise to the highest priority. Additionally, TRUMPF will issue a new approved cleaning and disinfection instruction, since investigations have shown that the cracking is significantly influenced by the use of certain disinfectants containing alcohol. The operator manual previously stated to avoid using alcohol-based cleaners on some parts of the ILED, but after reviewing this it was determined that it was not clearly stated to avoid use on the covers.

Device

Device Recall ILED Surgical Light
  • Modèle / numéro de série
    Serial numbers: 100268621 to 100717475
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution.
  • Description du dispositif
    ILED Surgical Light, Model numbers: ILED3, ILED5 and ILED5K
  • Manufacturer
    Trumpf Medical Systems, Inc.

Manufacturer

Trumpf Medical Systems, Inc.
  • Adresse du fabricant
    Trumpf Medical Systems, Inc., 415 Jessen Ln, Charleston SC 29492
  • Société-mère du fabricant (2017)
    Hill-Rom Holdings, Inc
  • Source
    USFDA