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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 Aimersee related information
Date Initiated by FirmMay 22, 2014
Date PostedJune 08, 2015
Recall Status1 Terminated 3 on June 24, 2015
Recall NumberZ-1638-2015
Recall Event ID 71298
510(K)NumberK123603 
Product Classification Image-intensified fluoroscopic x-ray system, mobile - Product Code OXO
ProductGE 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.
FEI Number 1720753
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
ActionGE 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 Commerce9
DistributionUS Distribution to the states of: MD, NC, MT, NJ, UT and NY
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.
510(K) Database510(K)s with Product Code = OXO
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