Events

Rappel de Device Recall Visum LED Surgical Lights

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 Stryker Communications Corp.

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
    60812
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0913-2012
  • Date de mise en oeuvre de l'événement
    2011-11-07
  • Date de publication de l'événement
    2012-01-26
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-08-17
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=106527
  • 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
    Stryker has identified a potential structural issue with the visum led surgical light(s). during a complaint investigation, stryker became aware that there was a possibility that incorrect assembly could result in the light head beginning to separate from the suspension arm. in the event the light separates and falls from the arm, it could lead to serious injury.
  • Action
    The firm sent "Urgent: Medical Device Correction" letters dated 11/07/2011 to their domestic and international customers. The letter informed customers of the remote risk of the light detaching from the arm and recommended continued use of the product. A representative will contact them about scheduling an appointment to inspect the lights. Contact Technical Services at 1-866-841-5663 for questions.

Device

Device Recall Visum LED Surgical Lights
  • Modèle / numéro de série
    Catalog Number: 0682001250, 0682001251, 0682001252, and 0682001253.   Product Numbers: P10235 (Visum LED Surgical Light, Camera Ready), P10234 (Visum LED Surgical Light), P12875 (Visum LED Surgical Light Camera Ready - Low Ceiling), P12874 (Visum LED Surgical Light - Low Ceiling).   Expiration date: There is no expiration date with the scope of the action. Serial Numbers: Product manufactured between October 2010 to July 2011 and in use by customer.
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA, and the countries of Australia, Canada, Hong Kong, Brazil, Sweden, India, Japan, Korea, Ecuador, Venezuela, Mexico, Denmark, Great Britain, and New Zealand.
  • Description du dispositif
    Visum LED Surgical Lights, Ceiling Mounted Surgical Light. The Visum LED surgical light is intended to illuminate the operative site during surgical procedures with high intensity light.
  • Manufacturer
    Stryker Communications Corp

Manufacturer

Stryker Communications Corp
  • Adresse du fabricant
    Stryker Communications Corp, 1410 Lakeside Pkwy Ste 100, Flower Mound TX 75028-4026
  • Société-mère du fabricant (2017)
    Stryker
  • Source
    USFDA