Events

Rappel de Karl Storz Photodynamic Diagnosis (PDD) DLight C 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 Karl Storz Endoscopy America 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
    60555
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1216-2013
  • Date de mise en oeuvre de l'événement
    2012-08-16
  • Date de publication de l'événement
    2013-05-08
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-05-08
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=117240
  • 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 source system, diagnostic endoscopic - Product Code OAY
  • Cause
    The recall was initiated because karl storz has confirmed that the photodynamic diagnosis (pdd) d-light c system instruction manuals have important safety-related changes.
  • Action
    A Safety Alert letter, dated 8/16/12, was sent to all their customers to inform them that there is a labeling error in which important safety-related changes were made to the KARL STORZ Photodynamic Diagnosis (PDD) D-Light C System instruction manuals. The correct Ethylene Oxide (EtO) Sterilization set point for Relative Humidity should read, =70% RH. The correction applies to the PDD Camera Head instruction manual, PDD Rigid Telescopes instruction manual, and Tricam SL II instruction manual, the three component manuals indicated for use within the KARL STORZ Photodynamic Diagnosis (PDD) D-Light C System. The letter instructed the customers to place each of the three enclosed stickers, in the appropriate instruction manual. Customers are instructed to cover the erroneous information with the provided stickers as indicated. Customers with any questions regarding the proper use of the device, are instructed to contact Karl Storz's Technical Support Department at 800-421-0837, Ext. 5350, during office hours; or Ext. 7222, 24 hours/7 days a week for emergencies.

Device

Karl Storz Photodynamic Diagnosis (PDD) DLight C System,
  • Modèle / numéro de série
    The device Instruction Manual recall, which includes: 1) Telescope, 2) Camera Head, and 3) Camera System.   Serial Numbers: ZZ2008 ZZ2016 ZZ2012 ZZ2019 TY2024 ZZ2013 TY2026 TY2025 TY2028 TY2021 ZZ2007 ZZ2020 TX2036 TX2033 ZZ2017, and  TX2035.
  • Classification du dispositif
    Gastroenterology-Urology Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide distribution: USA including states of: IL, CA, WV, TX, SC, WI, NY, PA, NE, NJ, MD, OH, IA, and NC.
  • Description du dispositif
    KARL STORZ Photodynamic Diagnosis (PDD) D-Light C System, || Instruction Manuals: PDD Telescopes, Tricam SL II, and PDD Camera Heads. || Used as an optional accessory to white light cystoscopy when used in combination with the diagnostic imaging drug Cysview.
  • Manufacturer
    Karl Storz Endoscopy America Inc

Manufacturer

Karl Storz Endoscopy America Inc
  • Adresse du fabricant
    Karl Storz Endoscopy America Inc, 2151 East Grand Avenue, El Segundo CA 90245
  • Société-mère du fabricant (2017)
    Karl Storz SE & Co. KG
  • Source
    USFDA