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U.S. Department of Health and Human Services

Class 2 Device Recall Precision 500D

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  Class 2 Device Recall Precision 500D see related information
Date Initiated by Firm June 10, 2010
Date Posted May 06, 2011
Recall Status1 Terminated 3 on September 15, 2014
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 WI 53188-1615
For Additional Information Contact
262-513-4122
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
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 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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