—#96018

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.

FDA product code: JAA — System, X-Ray, Fluoroscopic, Image-Intensified
Device class: Class 2
Medical specialty: Radiology
Affected lot / code info: Part number 5234960.

Why it was recalled

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.

Root cause (FDA determination)

Radiation Control for Health and Safety Act

Action the firm took

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.

Recalling firm

Firm: GE Healthcare, LLC
Address: 3000 N Grandview Blvd, Waukesha, Wisconsin 53188-1615

Distribution

Distribution pattern: Nationwide Distribution

Timeline

Recall initiated: 2010-06-10
Posted by FDA: 2011-05-06
Terminated: 2014-09-15
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #96018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.