Events

Recall of PCS125 Swivel Collimator, Model F100

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Summit Industries 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
    38512
  • Event Risk Class
    Class 2
  • Event Number
    Z-1218-2007
  • Event Initiated Date
    2007-08-10
  • Event Date Posted
    2007-08-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-03-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=54590
  • 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
    Radiographic Collimator - Product Code IZX
  • Reason
    The f100 swivel collimator may come loose from the tubestand and fall onto the x-ray table.
  • Action
    The affected dealers were notified of the field correction recall by letter dated 8/3/07, informing them of the problem with the stripped screws and requesting that they notify their affected end user locations. The end user notification letters inform them of the problem and state that the dealer will be contacting them soon to arrange a time to visit the end user location and conduct the rework on the collimator, which should take less than 30 minutes. In the mean time the end user was instructed to examine their swivel collimator for looseness. If it is found to be loose, the end user was instructed to take the unit out of service and call the dealer.

Device

PCS125 Swivel Collimator, Model F100
  • Model / Serial
    Model F100, serial numbers WA153-1092 to WA153-0697, all swivel units manufactured between 10/01/1992 and 06/30/1997
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide, including USA, Australia, Cambodia, Canada, Chile, Colombia, Dominican Republic, Ecuador, France, Germany, Haiti, Mexico, Nicaragua, Singapore, and South Africa.
  • Product Description
    PCS125 Swivel Collimator, Model F100; Manual Radiographic Collimator; Summit Industries, Inc., Chicago, Illinois
  • Manufacturer
    Summit Industries Inc.

Manufacturer

Summit Industries Inc.
  • Manufacturer Address
    Summit Industries Inc., 2901 W Lawrence Ave, Chicago IL 60625-3621
  • Source
    USFDA