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U.S. Department of Health and Human Services

Class 2 Device Recall Precision 500D

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 Class 2 Recall
Precision 500D
see related information
Date Posted May 06, 2011
Recall Status1 Open
Recall Number Z-1971-2011
Recall Event ID 57383
Product Classification System, X-Ray, Fluoroscopic, Image-Intensified - Product Code JAA
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.
Code Information Part number 5234960.
Recalling Firm/
Manufacturer
GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha, Wisconsin 53188-1615
Consumer Instructions No consumer action necessary
Manufacturer Reason
for Recall
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.
FDA Determined
Cause 2
RADIATION CONTROL FOR HEALTH AND SAFETY ACT: Radiation Control for Health and Safety Act
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.
Quantity in Commerce 440 US
Distribution Nationwide Distribution
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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