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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 Systemsee related information
Date Initiated by FirmJanuary 29, 2016
Date PostedMarch 08, 2016
Recall Status1 Terminated 3 on March 10, 2016
Recall NumberZ-1088-2016
Recall Event ID 73303
510(K)NumberK151000 
Product Classification Interventional fluoroscopic x-ray system - Product Code OWB
ProductMedtronic 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
FEI Number 3004785967
Recalling Firm/
Manufacturer		 Medtronic Navigation, Inc.
300 Foster St
Littleton MA 01460-2017
For Additional Information ContactSAME
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
ActionMedtronic 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 Commerce1 unit
DistributionWorldwide Distribution to Austria only.
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 = OWB
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