Rappel de InfraVision IR Illuminator Console

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 Endoscopy.

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
  • ID de l'événement
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
  • Date de publication de l'événement
  • Statut de l'événement
  • Pays de l'événement
  • Date de fin de l'événement
  • Source de l'événement
  • URL de la source de l'événement
  • 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
    Carrier, sponge, endoscopic - Product Code FGS
  • Cause
    Product may not adequately visualize ir light emitted from u- and e- kits due to a manufacturing error.
  • Action
    The firm, Stryker Endoscopy, sent an "Urgent: Device Correction" letter dated September 28, 2010, t o all consignees/customers via a Fed Ex Mailer that included notification letter, acknowledgment receipts and updated instructions for use. International Stryker sites received product advisory notification. Stryker reps at those sites are responsible for notifying customers. The letter described the product, problem and actions to be taken by the customers. The customers were instructed to discard any old IFUs from the InfraVision Console and ensure that they only use InfraVision compatible scopes; read the newly updated IFU provided with the letter; and complete and sign the enclosed "acknowledgement of receipt" form and fax to (408) 754-8378 or scan in or email to infravision@stryker.com. Note: Not returning the "acknowledgement of receipt" card will result in additional notices. Please contact your local Stryker sales representative to obtain information on scopes that are specific to the InfraVision system. If you have any questions, please contact us at 1-800-624-4422 or email at infravision@stryker.com.


  • Modèle / numéro de série
    All lots and serial numbers are affected.
  • Classification du dispositif
  • Classe de dispositif
  • Dispositif implanté ?
  • Distribution
    Worldwide distribution: USA and countries including: Australia, Africa, Brazil, Canada, China, France, Greece, India, Italy, Korea, Latin America Mexico, New Zealand, Portugal, Romania, Singapore, Sweden, Switzerland, Taiwan, Thailand, and United Kingdom.
  • Description du dispositif
    InfraVision IR Illuminator Console, model number 220-180-521, manufactured by Stryker Endoscopy San Jose, for use with the Stryker InfraVision system. || Intended use:Medical device for human use, during surgical procedures to transilluminate anatomical structures during surgical procedures with infrared light. It can be used in either open surgical interventions or during laparoscopic procedures. infrared light which is not visible to the human eye is detected by all of Stryker's infrared sensitive cameras. The InfraVision console outputs the infrared light via disposable fibers hooked to the console that are contained in either the E-kit or the U-kit.
  • Manufacturer


  • Adresse du fabricant
    Stryker Endoscopy, 5900 Optical Ct, San Jose CA 95138-1400
  • Société-mère du fabricant (2017)
  • Source