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U.S. Department of Health and Human Services

Class 2 Device Recall Medtronic Oarm Imaging System

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  Class 2 Device Recall Medtronic Oarm Imaging System see related information
Date Initiated by Firm July 25, 2013
Date Posted February 28, 2014
Recall Status1 Terminated 3 on April 17, 2019
Recall Number Z-0973-2014
Recall Event ID 67363
510(K)Number K092564  
Product Classification Image-intensified fluoroscopic x-ray system, mobile - Product Code OXO
Product Medtronic O-arm Imaging System Mobile X-ray system.
Model No. BI-700-00027 and BI-700-00028

The 0-arm 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 0-ann Imaging System is compatible with certain Image Guided Surgery Systems.
Code Information Model No. BI-700-00027 and BI-700-00028 Serial number range: 00102 through 00753 and B13080721, B13080722, B13090729, B13120763, B13120764, B13120766, B13120768, B13120769
Recalling Firm/
Manufacturer		 Medtronic Navigation, Inc.
300 Foster St
Littleton MA 01460-2017
For Additional Information Contact
978-698-6000
Manufacturer Reason
for Recall		 Review of on-system electronic product labeling and Instructions for comply with applicable Use in response to a customer inquiry uncovered gaps in compliance FDA standards with the requirements for information to be provided to users in 21CFR 1020.30(h)
FDA Determined
Cause 2		 Radiation Control for Health and Safety Act
Action Medtronic Navigation Inc. issued Notiifcation on 3/4/14 and included thee errata sheet to all affected customers updating the missing and incorrect information and ensure that labeling is now in compliance with 21 CFR Part 1020.30(h). This will be followed by a software update that contains the same information on the errata sheet, which serves to correct the electronic version of the Instructions for Use. The paper errata sheet will be sent via traceable means and the software upgrade will be performed by Medtronic Service either through remote access or by site visit of Medtronic service personnel. For further questions please call (978) 698-6000.
Quantity in Commerce 449 in US
Distribution USA (nationwide) 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 = MEDTRONIC NAVIGATION, INC. (LITTLETON)
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