Events

Rappel de Device Recall TruLight ALC, Trulight 5520 or 5320 lighting 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 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
    61004
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1010-2012
  • Date de mise en oeuvre de l'événement
    2012-01-09
  • Date de publication de l'événement
    2012-02-13
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-10-09
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107025
  • 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
    Light, surgical, ceiling mounted - Product Code FSY
  • Cause
    The alc+ function may not be properly locked during use resulting in the possibility of the handle falling off into the surgical field causing injury to the patient.
  • Action
    The firm, TRUMPF Medical Systems, Inc., sent an "Urgent Safety Information" notice/package dated January 9, 2012 to its customers. (Note: Some were delivered by TRUMPF representatives in person and some via mail with Urgent Safety identification on the envelope). The notice describes the product, problem and actions to be taken. TRUMPF will replace all sterilizable handles of this type in the field with new handles, in addition, TRUMPF will send new handles and verify disposal of the old version at the customers location. Distribution of new handles will start January 2012. The customers were instructed to ensure that all users and other relevent persons are informed of the Urgent Safety Information; store the information until the measure has been completed and complete and return the Confirmation of User Receipt form via mail to TRUMPF Medical Systems, Inc. 1046 LeGrand Blvd., Charleston, SC 29063 or email: Lindsey.ronnenberg@us.trumpf-med.com. If you have any questions, call 843-822-6939.

Device

Device Recall TruLight ALC, Trulight 5520 or 5320 lighting system.
  • Modèle / numéro de série
    Material number 1583966
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution: USA (nationwide) including states of: AL, CA, CO, CT, DE, FL, GA, IL, IN, MA, MD, MO, NC, NM, NJ, NY, OH, PA, TX, VA, VT, WA, and WI; and countries of: Australia; Austria, Belguim, China, Cyprus, Denmark, Estonia, Finland, France, Germany, Great Britain, Hong Kong, Indonesia, India, Ireland, Italy, Japan, Kazakhstan, Kenya, Korea, Latvia, Luxembourg, Mexico, Netherlands, Norway, Pakistan, Peru, Philippines, Poland, Romania, Russian Federation, Saudi Arabia, Seychelles, Singapore, South Africa (Zuid Afirka), Spain, Sweden, Switzerland (Confederation of Helvetia), Taiwan, Thailand, Tunisia, Turkey, Uruguay, Venezuela, and Viet Nam.
  • Description du dispositif
    Surgical lighting systems iLED and TruLight in use with the ALC+ function. || The TRUMPF surgical lights are intended to locally illuminate an operating or examination area of the patients body with a high intensity light.
  • 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