Events

Recall of Device Recall Fiducial Markers, Sterile (0.9 x 3 mm) Soft tissue gold markers

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Med Tec Inc dba CIVCO Medical Solutions.

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
    46905
  • Event Risk Class
    Class 3
  • Event Number
    Z-1614-2008
  • Event Initiated Date
    2008-02-28
  • Event Date Posted
    2008-05-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-07-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=68456
  • 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
    Medical charged-particle radiation therapy system - Product Code IYE
  • Reason
    Mislabeled: fiducial markers were incorrectly labeled. they are marked (0.9x3mm cylindrical) soft tissue gold markers, but contain (2mm spheres) bone gold markers.
  • Action
    Consignees were notified via telephone beginning 2/28/08 and a Recall Notification letter sent on 2/29/08. Users were requested to return any affected products for a replacement. They were also requested to return a recall notification form indicating the amount of affected product in their inventory. For additional information, call 800-842-8688.

Device

Device Recall Fiducial Markers, Sterile (0.9 x 3 mm) Soft tissue gold markers
  • Model / Serial
    Lot Number: 080117-02
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including states of WA, PA, DE, AL, CT, WI, FL, TX, MN, and IL.
  • Product Description
    Fiducial Markers (0.9 x 3 mm) Soft tissue gold markers, Medical charged-particle radiation therapy system; Part Number: MT-NW-887-809, CIVCO Medical Solutions (MEDTEC), Orange City, IA 51041.
  • Manufacturer
    Med Tec Inc dba CIVCO Medical Solutions

Manufacturer

Med Tec Inc dba CIVCO Medical Solutions
  • Manufacturer Address
    Med Tec Inc dba CIVCO Medical Solutions, 1401 8th St, PO Box 320, Orange City IA 51041-0320
  • Manufacturer Parent Company (2017)
    Roper Technologies Inc
  • Source
    USFDA