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U.S. Department of Health and Human Services

Class 2 Device Recall GE OEC Brivo 865 Plus

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  Class 2 Device Recall GE OEC Brivo 865 Plus see related information
Date Initiated by Firm September 15, 2014
Date Posted January 13, 2015
Recall Status1 Terminated 3 on May 20, 2015
Recall Number Z-0841-2015
Recall Event ID 69660
510(K)Number K123603  
Product Classification Image-intensified fluoroscopic x-ray system, mobile - Product Code OXO
Product GE OEC Brivo 865 Plus Mobile C-Arm X-Ray Product

Used for general surgical applications and musculoskeletal procedures to visualize.
Code Information GE OEC Brivo 865 Plus Serial Numbers:  B4S13011 B4S13012 B4S13016 B4S13018 B4S13020 B4S13029 B4S13031 B4S13035 B4S13038 B4S13043 B4S13054 B4S13056 B4S13059- B4S13061 B4S14002- B4S14004 B4S14007 B4S14015 B4S14016 B4S14022 B4S14022 B4S1403 3 B4S1403 4    
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		 mA Accuracy may exceed the design and labeling specification of+ 10%. Per 1020.32(f): Deviation of x-ray tube potential and current from the indicated values shall not exceed the maximum deviation as stated by the manufacturer in accordance with 1020.30(h)(3).
FDA Determined
Cause 2		 Radiation Control for Health and Safety Act
Action Planned action(s) to repair defect or to bring product into compliance: GE Healthcare will, without charge, perform a mA calibration on all affected systems in the USA to bring the product back into compliance. The details of which will be included in a subsequent communication to customers or through a GE Healthcare field engineer site visit. Should customers have any questions or concerns regarding these corrections, please do not hesitate to contact the service team for further information at 800-874-7378 option 8.
Quantity in Commerce 61 units installed in US
Distribution Worldwide 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.
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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