Events

Recall of Medrad Overhead Couterpoise System II

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Medrad 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
    33816
  • Event Risk Class
    Class 2
  • Event Number
    Z-0089-06
  • Event Initiated Date
    2005-10-07
  • Event Date Posted
    2005-10-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-11-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=42490
  • 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, Tomography, Computed - Product Code JAK
  • Reason
    Overhead system can fall due to the failure of a retaining ring.
  • Action
    The recalling firm issued an Urgent Medical Device Field Correction notice dated 10/7/05 to all customers. The notice informs customers of the problem and cautions anyone to be under the system when in use. The notice also informs the customer that a firm representative will schedule a time to perform the upgrade. On 10/13/05, the recalling firm also issued a notification to scanner manufacturers alerting them of the problem.

Device

Medrad Overhead Couterpoise System II
  • Model / Serial
    All serial numbers
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The product was shipped to medical facilities nationwide. The product was also shipped to Austria, Belgium, Chile, Czech, Denmark, Spain, Finland, France, Great Britain, Ireland, Israel, Italy, Netherlands, Norway, Sweden, Austrailia, Kuwait, Saudia Arabia, Canada, China, Hong Kong, India, Korea, Singapore, Taiwan, Brazil, Columbia, Cuba, Mexico, and Japan.
  • Product Description
    Medrad Overhead Counterpoise System II. Support Arm. Mount Injector Head. Catalog numbers 3010544, 3010545, 3010546, 3010547, 3010548, 3010549, 3010550, 3010551, 3010552, and 3010553.
  • Manufacturer
    Medrad Inc

Manufacturer

Medrad Inc
  • Manufacturer Address
    Medrad Inc, 1 Medrad Dr, Indianola PA 15051-9759
  • Source
    USFDA