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U.S. Department of Health and Human Services

Class 2 Device Recall Bladeline Cabinet Xray system

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  Class 2 Device Recall Bladeline Cabinet Xray system see related information
Date Initiated by Firm June 28, 2017
Create Date August 01, 2017
Recall Status1 Terminated 3 on February 06, 2020
Recall Number Z-2777-2017
Recall Event ID 77756
Product Classification Cabinet x-ray, industrial - Product Code RCE
Product GE Inspection Technologies Blade|line Industrial Cabinet X-ray system
Code Information Serial No.  TM 201317 TM 201312 TM 201323 TM 201331 TM 201401 TM 201329 TM 201404 TM 201413 TM 201414 TM 201415 TM 201424 TM 201425 158017R1
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		 GE Inspection Technologies, LP determined that the Blade|line cabinet x-ray system fails to comply with the cabinet x-ray performance standards emission limit of 0.5 milliRoentgen in one hour (21 CFR ¿ 1020.40(c)(1)(i)) underneath the bottom center of the system. The crawl space affected by the excess emission is approximately 22 inches high, normally covered by decorative panels, and is not intended to be accessed.
FDA Determined
Cause 2		 Radiation Control for Health and Safety Act
Action GE Inspection Technologies will bring the defect into compliance: 1. Four panels of sheet metal/lead/sheet metal construction (6 mm lead thickness) will be permanently mounted using an industrial epoxy to the inside floor of the cabinet to prevent emissions from exceeding the limit in the performance standard. A radiation emission measurement will be made following the repairs of each system to assure the issue was corrected. 2. GE will notify affected customers within 5 days of GEs receipt of this approval letter. 3. The notification will recommend that customers allow GE to visit the site and install the new shielding within 120 days following GEs receipt of this letter. 4.The text of the notification to customers will include the required statement that confirms that GE will, without charge, bring the affected cabinet x-ray systems into compliance with the performance standard. For further questions, please call (717) 447-1278.
Quantity in Commerce 13 units distributed in the US
Distribution US Distribution to the states of : AL, SC, OH, MI, PA, and Internationally to Germany and Singapore
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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