Events

Recall of Device Recall Precision 500D

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by GE Healthcare, LLC.

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
    57383
  • Event Risk Class
    Class 2
  • Event Number
    Z-1971-2011
  • Event Initiated Date
    2010-06-10
  • Event Date Posted
    2011-05-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-09-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=96018
  • 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, fluoroscopic, image-intensified - Product Code JAA
  • Reason
    Use of high force when moving the image carriage/idd into forward/park position can cause changes to the mechanical alignment of the collimator blades and allow the blades to open wider than specified, consequently allowing radiation outside the permitted field without warning to the user. this issue manifests with symptoms wherein the user cannot fully close down the lateral blades.
  • Action
    GE Healthcare sent an Importan Electronic Product Radiation Warning letter to customers. The letter discussed the product defect description and related hazards, affected product details, instructions, and product correction. The firm will send a GE Field Service Representative to visit each affected customer site to inspect and correct all potentially affected units in the field following the instructions in field modification instructions No: 10846. If you have any questions please call 800-437-1171.

Device

Device Recall Precision 500D
  • Model / Serial
    Part number 5234960.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    Precision 500D X-ray systems with under-table collimator part number 5234960. || The Precision 500D is designed to perform radiographic and fluoroscopic x-ray examinations.
  • Manufacturer
    GE Healthcare, LLC

Manufacturer

GE Healthcare, LLC
  • Manufacturer Address
    GE Healthcare, LLC, 3000 N Grandview Blvd, Waukesha WI 53188-1615
  • Manufacturer Parent Company (2017)
    General Electric Company
  • Source
    USFDA