Precision 500D X-ray systems with under-table collimator part number 5234960…

Date posted by the FDA

May 6, 2011

Status

Terminated

Filed by

GE Healthcare, LLC

Product

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.

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.

Distribution pattern

Nationwide Distribution

Quantity

440 US

Codes and lots

Part number 5234960.

Recall started

June 10, 2010

Device type

System, X-Ray, Fluoroscopic, Image-Intensified

Root cause (FDA)

Radiation Control for Health and Safety Act

What the company told customers

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.

Recall number

Z-1971-2011

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement report, recall number Z-1971-2011. The agency record governs; check it and the company before acting.