Events

Recall of Device Recall Del CTM and DCTM Ceiling Tube Mount

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Del Medical Systems Group.

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
    50841
  • Event Risk Class
    Class 2
  • Event Number
    Z-1247-2009
  • Event Initiated Date
    2009-01-12
  • Event Date Posted
    2009-06-30
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-06-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=77462
  • 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
    Del CTM and DCTM Ceiling Tube Mount - Product Code IYB
  • Reason
    There is the potential for the supporting cable to become detached from the column causing the column to fall and possibly contact the patient or operator.
  • Action
    Del Medical sent a "Field Correction Recall" letter with an acknowledgement form to the direct account dealers/assemblers on January 12, 2009 - February 4, 2009, informing them that required maintenance inspection of a retaining ring inside the column assembly may not be performed as required. If the retaining ring is not regularly inspected and replaced when worn or loose, there is the potential for the supporting cable to become detached from the column causing the column to fall and possibly contact the patient or operator. The accounts were requested to locate the affected systems and immediately take them out of service until correction by installing a Cable Mount Retention Retrofit Kit to eliminate the potential for the cable to become detached. Affected accounts were instructed to complete the enclosed acknowledgement form and return it via fax (847-288-7911) or mail to Del Medical. If there are any questions, please contact Del Medical Technical Support at 800-800-6006 or 847-288-7000.

Device

Device Recall Del CTM and DCTM Ceiling Tube Mount
  • Model / Serial
    All Model CTM and DCTM Ceiling Tube Mounts with either a 5 inch extension (Part 114-0304G2) or 10 inch extension (Part 114-0304G1). There are no serial numbers on the extensions.
  • Product Classification
    Radiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- US, Canada, Scotland and Pakistan.
  • Product Description
    Ceiling Tube Mount Ceiling Tube Mount (CTM)/Digital Ceiling Tube Mount (DCTM) with 5 inch or 10 inch Column Extensions; a radiographic x-ray tube suspension system designed to facilitate a wide range of procedures; Del Medical Systems Group, 11550 West King Street, Franklin Park, IL 60131-1330. || The device is used for X-Ray tube positioning.
  • Manufacturer
    Del Medical Systems Group

Manufacturer

Del Medical Systems Group
  • Manufacturer Address
    Del Medical Systems Group, 11550 West King Street, Franklin Park IL 60131-1330
  • Source
    USFDA