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U.S. Department of Health and Human Services

Class 2 Device Recall GE Healthcare DISCOVERY MODEL NM/CT 670

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  Class 2 Device Recall GE Healthcare DISCOVERY MODEL NM/CT 670 see related information
Date Initiated by Firm January 26, 2011
Date Posted July 21, 2011
Recall Status1 Terminated 3 on August 31, 2012
Recall Number Z-2158-2011
Recall Event ID 58419
Product Classification Monitor, patient position, light-beam - Product Code IWE
Product GE Healthcare DISCOVERY MODEL NM/CT 670

NM/CT system
Code Information Part # 5417918-1EN. 
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		 GE Healthcare has become aware of a missing laser aperture warning label (i.e. Laser Aperture - Do Not Stare Into Beam) affecting certain Discovery Systems.
FDA Determined
Cause 2		 Radiation Control for Health and Safety Act
Action GE Healthcare will bring affected systems into compliance. A GE Healthcare Service Representative will provide a product label correction to address this issue. This will be carried out via a Field Modification Instruction (FMVI 408311 planned to be released in June 2011 with an estimated completion date of August 2011. For questions call 262-513-4122.
Quantity in Commerce 4
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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