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U.S. Department of Health and Human Services

Class 2 Device Recall GE Cabinet Xray system

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  Class 2 Device Recall GE Cabinet Xray system see related information
Date Initiated by Firm January 13, 2015
Date Posted March 20, 2015
Recall Status1 Terminated 3 on August 17, 2015
Recall Number Z-1225-2015
Recall Event ID 70478
Product Classification Cabinet x-ray, industrial - Product Code RCE
Product GE Inspection Technologies x|argos 160D system. Cabinet x-ray system.
Code Information SN - PA1053
Recalling Firm/
Manufacturer		 GE Inspection Technologies, LP
50 Industrial Park Rd
Lewistown PA 17044-9312
For Additional Information Contact
717-447-1278
Manufacturer Reason
for Recall		 It was discovered that the upper left corner-shaped lead shield in the window in one of the doors installed had lost adhesion and fall out of position, which could lead to gaps in shielding.
FDA Determined
Cause 2		 Device Design
Action GE Inspection Technologies, Planned Action: 1. GE will notify customers of the affected cabinet x-ray systems through a Technical Information Letter. GE notified its affected customers via email on January 13, 2015, via letter dated January 14, 2015, and via telephone on January 19, 2015. 2.GE will install an interim insert within 30 days of receipt of this letter. The insert will cover any existing or interim gaps in the original lead shielding on the door. 3. GE will replace the doors of affected cabinet x-ray systems no later than 180 day of receipt of this letter. 4. These corrections will be made free of charge. The Technical Information Letter used for notification of all dealers and purchasers is to be made within 15 working days of receipt of this letter For further questions, please call (717) 447-1278
Quantity in Commerce 2
Distribution US Distribution to the states of OH and PA.
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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