Events

Recall of Karl Storz Photodynamic Diagnosis (PDD) DLight C System,

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Karl Storz Endoscopy America Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    60555
  • Event Risk Class
    Class 2
  • Event Number
    Z-1216-2013
  • Event Initiated Date
    2012-08-16
  • Event Date Posted
    2013-05-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-05-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=117240
  • Notes / Alerts
    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.
  • Extra notes in the data
    Light source system, diagnostic endoscopic - Product Code OAY
  • Reason
    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,
  • Model / Serial
    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.
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Nationwide distribution: USA including states of: IL, CA, WV, TX, SC, WI, NY, PA, NE, NJ, MD, OH, IA, and NC.
  • Product Description
    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
  • Manufacturer Address
    Karl Storz Endoscopy America Inc, 2151 East Grand Avenue, El Segundo CA 90245
  • Manufacturer Parent Company (2017)
    Karl Storz SE & Co. KG
  • Source
    USFDA