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U.S. Department of Health and Human Services

Class 2 Device Recall Phoenix micromelx and nanomelx cabinet xray systems

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 Class 2 Device Recall Phoenix micromelx and nanomelx cabinet xray systemssee related information
Date Initiated by FirmDecember 16, 2015
Create DateApril 01, 2016
Recall Status1 Terminated 3 on October 14, 2016
Recall NumberZ-1231-2016
Recall Event ID 73364
Product Classification Cabinet x-ray, industrial - Product Code RCE
ProductGE Inspection Technologies, LP, Cabinet X-ray system used for industrial quality control.
Code Information phoenix micrornelx and nanomelx cabinet x-ray systems
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 ("GE") has discovered that certain of its cabinet x-ray systems may not fully comply with the Food and Drug Administration's (FDA) Cabinet X ray System performance standards, 21 C.F.R. 1020.40(c)(1)(i)
FDA Determined
Cause 2		Vendor change control
ActionGE Inspection Technologies Planned Action to bring into Compliance: 1. GE Inspection Technologies will use their updated adhesive procedure to install new brackets to the bottom left and right lead strips in the control door. The new procedure and brackets were developed in November 2013. 2. A second notification of customers with affected systems will be sent within 5 days of approval of this CAP. This notification will describe the repair above and propose that a GE technician visit each site and install the described repair. 3. Repairs will be completed within 120 days after approval of this CAP and will be made free of charge. For further questions, please call (717) 447-1278. ;
Quantity in Commerce55 US Distribution
DistributionUS Distribution to the states of : TX, MD, MI, CA, TN, NH, NY, AL, NC, ID, MA, AZ, IN, FL, PA, NJ, WI, VA, MN, MD CO, GA, SC, OH and DC.
Total Product Life CycleTPLC 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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