Events

Recall of Device Recall Performix

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by General Electric Med Systems.

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
    27927
  • Event Risk Class
    Class 2
  • Event Number
    Z-0306-04
  • Event Initiated Date
    2003-12-08
  • Event Date Posted
    2004-01-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-11-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=30756
  • 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
    Tube Mount, X-Ray, Diagnostic - Product Code IYB
  • Reason
    Incorrect mounting hardware may cause x-ray tube to separate from the gantry and fall.
  • Action
    Field Modification Instructions (FMI''s) will be issued to the field to inspect and locate suspect tubes and replace any that may be susceptible to failure.

Device

Device Recall Performix
  • Model / Serial
    Tube Catalog #''s D3132, D3172, D3182, and D3152 used on Gantry model #''s 2137130, 2137130-5, 2234921-3, 2260619, 2260619-3, 2281177, 2281177-2, 2281177-3, 2281177-4, 2305500, 2339985, 2341799, 2362605, and 5101272.
  • Product Classification
    Radiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Distributed nationwide throughout the US and worldwide.
  • Product Description
    Performix X-ray Tube - Performix ADV, Performix Ultra, Solarix 630.
  • Manufacturer
    General Electric Med Systems

Manufacturer

General Electric Med Systems
  • Manufacturer Address
    General Electric Med Systems, 3000 N Grandview Blvd, Waukesha WI 53188-1615
  • Source
    USFDA