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U.S. Department of Health and Human Services

Class 2 Device Recall GE Inspection Technologies Phoenix vtomex M240 cabinet xray systems.

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  Class 2 Device Recall GE Inspection Technologies Phoenix vtomex M240 cabinet xray systems. see related information
Date Initiated by Firm March 02, 2016
Date Posted July 23, 2016
Recall Status1 Terminated 3 on August 07, 2017
Recall Number Z-2236-2016
Recall Event ID 74554
Product Classification Cabinet x-ray, industrial - Product Code RCE
Product GE Inspection Technologies, LP - Phoenix v|tome|x m240 cabinet x-ray systems.

A microfocus CT system used primarily for 3D metrology and analysis.
Code Information SN - PA2384
Recalling Firm/
Manufacturer		 GE Inspection Technologies, LP
50 Industrial Park Rd
Lewistown PA 17044-9312
For Additional Information Contact
717-242-0327
Manufacturer Reason
for Recall		 Radiation emissions which exceeded the limit in the performance standard were detected during maintenance of one system. The identified cause was insufficient attachment of shielding in the door. Jostling during delivery was identified as the probable cause of this failure to comply with the performance standard.
FDA Determined
Cause 2		 Radiation Control for Health and Safety Act
Action GE plans to notify its customers with the systems through a TIL. The TIL will inform customers that GE will add lead strips to the inside window frame under the lead glass window of the main cabinet door. GE recommends that it visit each customer site and repair the system by adding lead strips along the window frame of the cabinet door, beneath the lead glass window, within 90 days following FDA's approval of the repair plan.
Quantity in Commerce 4
Distribution US Distribution to the states of : FL, TN, and TX.
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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