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Class 2 Device Recall GE Healthcare Surgery OEC MiniView 6800 |
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Date Initiated by Firm |
December 19, 2016 |
Date Posted |
January 09, 2017 |
Recall Status1 |
Terminated 3 on August 22, 2017 |
Recall Number |
Z-0974-2017 |
Recall Event ID |
76033 |
510(K)Number |
K992506
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Product Classification |
Image-intensified fluoroscopic x-ray system, mobile - Product Code OXO
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Product |
OEC MiniView 6800. MDL Number: D002533 The OEC MiniView 6800 Digital Mobile C-Arm is designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imaging. The device is not intended for whole-body pediatric imaging |
Code Information |
Manufactured between 1/1/16 to 11/1/16 |
Recalling Firm/ Manufacturer |
GE OEC Medical Systems, Inc 384 N Wright Brothers Dr Salt Lake City UT 84116-2862
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For Additional Information Contact |
Deena Pease 801-536-4952
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Manufacturer Reason for Recall |
GE Healthcare Surgery announces a voluntary field action for the OEC MiniView 6800, OEC 9900 Elite, and OEC 9800 because the workstation power cable assembly can result in intermittent power cord failures.
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FDA Determined Cause 2 |
Use error |
Action |
GE Healthcare sent an Urgent Medical Device Correction letter dated December 19, 2016, to all affected consignees. GE informed consignees that GE will correct all affected products. If consignnes have any questions or concerns regarding this notification, please contact GE Healthcare Service at 1-800-437-1171 or their local Service Representative.
For questions regarding this recall call 801-536-4952. |
Distribution |
Worldwide Distribution - US including U.S. States: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS,
NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PUERTO RICO, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and Internationally to Canada, Mexico, and Costa Rica |
Total Product Life Cycle |
TPLC Device Report
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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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510(K) Database |
510(K)s with Product Code = OXO and Original Applicant = GE DEC MEDICAL SYSTEMS
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