Events

Recall of Device Recall LUNA Chest, Model No. LU4006

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Novadaq Technologies, 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
    69839
  • Event Risk Class
    Class 3
  • Event Number
    Z-0469-2015
  • Event Initiated Date
    2014-11-04
  • Event Date Posted
    2014-12-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-11-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=131610
  • 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
    System, x-ray, angiographic - Product Code IZI
  • Reason
    Non sterile-drape luna drape was inadvertently mislabeled with an additional contents sterile label.
  • Action
    Novadaq initiated their recall by telephone and followed by an email and a Medical Device Recall Notice dated November 11, 2014, to all affected customers. Distributors were instructed to notify their customers. The firm is removing the recalled products and replacing them with correctly labeled product. Customers were instructed to confirm receipt of the Recall Notice and their understanding of the actions to be taken by completing the attached confirmation form and faxing it to Novadaq Quality Department at 1-800-886-2419. For questions regarding this recall call 604-432-9861.

Device

Device Recall LUNA Chest, Model No. LU4006
  • Model / Serial
    Kit Lot Numbers: 13116, 14012, 14017, 14056, 14074, 14103, 14107 Drape Lot Numbers: D132172, D132602, D162692, D132602, D132712, D141002, D130282
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution to IA, LA, GA, MD, ID, FL, TN, OH, TX, NC, MA, KY, KS, WI, IN, SC, OR, CT, CA, WA, PA, OK, and PR.
  • Product Description
    LUNA Chest, Model No. LU4006
  • Manufacturer
    Novadaq Technologies, Inc.

Manufacturer

Novadaq Technologies, Inc.
  • Manufacturer Address
    Novadaq Technologies, Inc., 13155 Delf Place, Richmond Canada British Columbia
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    USFDA