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U.S. Department of Health and Human Services

Class 2 Device Recall Medtronic Oarm O2 Imaging System

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  Class 2 Device Recall Medtronic Oarm O2 Imaging System see related information
Date Initiated by Firm January 29, 2016
Date Posted March 08, 2016
Recall Status1 Terminated 3 on March 10, 2016
Recall Number Z-1088-2016
Recall Event ID 73303
510(K)Number K151000  
Product Classification Interventional fluoroscopic x-ray system - Product Code OWB
Product Medtronic 0-arm 02 Imaging System
Catalog Number: Bl-700-02000
The O-arm O2 Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging and is intended to be used where a physician benefits from 2D and 3D information of anatomic structures and objects with high x-ray attenuation such as bony anatomy and metallic objects.

The O-arm O2 Imaging System is compatible with certain image guided surgery systems.
Code Information Serial Number: C0936
Recalling Firm/
Manufacturer		 Medtronic Navigation, Inc.
300 Foster St
Littleton MA 01460-2017
For Additional Information Contact SAME
978-698-6000
Manufacturer Reason
for Recall		 Screws holding the detector panel in as a result the detector panel could make contact with other parts with in the 0-arm¿ 02 Imaging System, causing noise and vibration when being positioned or during 3D Imaging could lead to poor image quality
FDA Determined
Cause 2		 Process control
Action Medtronic Navigation issued a Field Safety Notice dated January 29, 2016, to notify them of a hardware correction in the unit. A Medtronic service representative will service the system and arrange for an inspection of the system. This representative will properly torque the eight (8) screws if they find them to be loose. In the meantime, if noise or vibration are observed during use of the system customers should contact their Medtronic representative to report the issue. Customers with questions were instructed to call 720-890-3160. For questions regarding this recall call 978-698-6000.
Quantity in Commerce 1 unit
Distribution Worldwide Distribution to Austria only.
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 = OWB and Original Applicant = MEDTRONIC INC.
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