• Topic ID: id_15460846
  • Version: 3.0
  • Date: Apr 9, 2020 8:47:51 PM

Certified Component Replacement Guidance

1 Certified Components

The replacement procedures for certified components can be found on the Service Methods CD in the replacement procedures, or in Service Installation Manual. When performing component replacement, ensure all steps of the procedures are followed and completed.

The FDA 2579 form and the e4879 forms are available on CDL, or click here: Certified Component Verification Form e4879 to download.

Certified components as defined by the FDA & GE Healthcare:

  • Collimator Assembly

  • X-Ray Tube

  • High Voltage Generator

    (High Voltage Tank is the Certified Component for the generator)

  • Gantry

  • Console Master Control

  • Table

2 Component Replacement

Follow the CT System De-Installation for removal and the System Installation Manual for replacement of the Gantry, Table and Console.

Follow the instructions in the replacement procedures for the Collimator, High Voltage Generator/Tank and X-Ray Tube.

3 Forms

All forms must be completed and submitted.

3.1 GE Form e4879

The Field Engineer should:

  1. Locate the GE form e4879.

  2. Complete the form.

  3. For GE employees, return the completed form with the FDA 2579 form.

3.2 FDA Form e2579   (US Only)

The Field Engineer should complete the FDA Form 2579 and return it per local procedures.

note: Some US States require a State Registration Number to complete this form, or additional information and test information.

3.3 Product Locator Cards

The Field Engineer should:

  1. Verify the certified component has GE rating plate and matching Production Locator Card.

  2. Enter the Product Locator Card information on the Product locator Website.

    Go to the following address to access the site: http://gib.gehealthcare.com/gib/gib_entry.jsp

    Or, mail in the cards on the address provided on the card.