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U.S. Department of Health and Human Services

Class 2 Device Recall GE OEC Brivo 865 plus Laser Aimer

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  Class 2 Device Recall GE OEC Brivo 865 plus Laser Aimer see related information
Date Initiated by Firm May 22, 2014
Date Posted June 08, 2015
Recall Status1 Terminated 3 on June 24, 2015
Recall Number Z-1638-2015
Recall Event ID 71298
510(K)Number K123603  
Product Classification Image-intensified fluoroscopic x-ray system, mobile - Product Code OXO
Product GE OEC Brivo 865 plus, Mobile X-ray system laser aimer assemblies (part number 520002DW)
Code Information OEC Brivo 865 Plus serial numbers B4S13061, B4S14006, B4S14007, B4S13033, B4S13032, B4S13038, B4S13039, B4S13024, AND B4S13023.
Recalling Firm/
Manufacturer		 GE OEC Medical Systems, Inc
384 N Wright Brothers Dr
Salt Lake City UT 84116-2862
For Additional Information Contact
801-536-4516
Manufacturer Reason
for Recall		 Laser aimer assemblies were shipped without certification of the overall assembly or submitting a laser product report and therefore do not comply with the US regulations for laser products.
FDA Determined
Cause 2		 Radiation Control for Health and Safety Act
Action GE Healthcare Surgery Planned Action(s) to repair the defect or to bring the product into compliance: The Center for Devices and Radiological Health (CDRH) understands that the CAP involving 9 units consisted of the following: 1. Replacing the tube side cover with the laser aimer assembly with a tube side cover without a laser aimer assembly. This correction brought the systems into compliance with applicable US regulations. For further questions please call (801) 536-4615.
Quantity in Commerce 9
Distribution US Distribution to the states of: MD, NC, MT, NJ, UT and NY
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.
510(K) Database 510(K)s with Product Code = OXO and Original Applicant = GE HEALTHCARE SURGERY GE OEC MEDICAL SYSTEMS, INC
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