Events

Recall of Captus 3000 Thyroid Uptake System with Portable Stand

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Capintec 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
    56975
  • Event Risk Class
    Class 2
  • Event Number
    Z-0167-2011
  • Event Initiated Date
    2010-09-20
  • Event Date Posted
    2010-10-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-07-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=95088
  • 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
    Calibrator, dose, radionuclide - Product Code KPT
  • Reason
    The spring arm on portable stand may have been over tightened during assembly, which may result in failure. if the spring arm fails, it will not balance the collimator weight, and the arm will drop to the lowest position.
  • Action
    Capintec issued an Alert letter to all customers identifying the affected device, informing them of the problem and what actions are to be taken by customers. Capintec will send a replacement arm for the system, which is to be installed by the customer using included instructions. The firm included a correction acknowledgement form to be completed and returned by the customer. Customers can contact Capintec concerning this recall at 201 825-9500.

Device

Captus 3000 Thyroid Uptake System with Portable Stand
  • Model / Serial
    Capintec item number 5430-2130, serial numbers: 91001, 91003 through 91010
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: USA in the states of NC and TN, and in the countries of Pakistan, Paraguay, Portugal, Saudi Arabia, and Spain.
  • Product Description
    Captus 3000 Thyroid Uptake System with Portable Stand option. Capintec item number 5430-2130, serial numbers: 91001, 91003 through 91010. Manufactured by Capintec, Inc, Pittsburgh, PA.
  • Manufacturer
    Capintec Inc

Manufacturer

Capintec Inc