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U.S. Department of Health and Human Services

Class 2 Device Recall Medtronic Navigation,

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  Class 2 Device Recall Medtronic Navigation, see related information
Date Initiated by Firm September 17, 2018
Create Date November 07, 2018
Recall Status1 Open3, Classified
Recall Number Z-0404-2019
Recall Event ID 81355
510(K)Number K173664  
Product Classification Interventional fluoroscopic x-ray system - Product Code OWB
Product Medtronic Navigation 0-arm 02 Imaging System interventional fluoroscopic x-ray system:

OARM BI70002000 SYS IMAGING 02
Model: BI70002000

OARM BI70002000R SYS IMAGING 02 REFURB
Model: BI70002000R
Code Information Serial Numbers:C0875 through C2012
Recalling Firm/
Manufacturer
Medtronic Navigation, Inc.-Littleton
300 Foster St
Littleton MA 01460-2017
For Additional Information Contact SAME
978-698-6000
Manufacturer Reason
for Recall
O-arm 02 Imaging Systems correction to software version 4.1.0; new version of the user manual and an Image Acquisition System ("IAS") product label; replacing blown fuse of the new AC power input circuit
FDA Determined
Cause 2
Software design
Action Medtronic Navigation issued Urgent Medical Device Correction letter on 9/27/18, notification letter advising, Medtronic field service personnel will install 4.1.0 software onto the designated consignee systems, update IFU and product labels as well as install a new designed AC power input circuit within the Mobile View Station {MVS). Questions regarding contact Medtronic Technical Support at 1-800-595-9709.
Quantity in Commerce 641 units
Distribution Worldwide Distribution - US Nationwide Foreign: AUSTRALIA AUSTRIA BAHRAIN BANGLADESH BELGIUM BRAZIL CANADA CHILE COLOMBIA DENMARK FINLAND FRANCE GERMANY HR ICELAND INDIA IRELAND ISRAEL ITALY JAPAN JORDAN KOREA, REPUBLIC OF LUXEMBOURG MARTINIQUE MEXICO NETHERLANDS NEW ZEALAND POLAND PORTUGAL PUERTO RICO QATAR SAUDI ARABIA SINGAPORE SOUTH AFRICA SPAIN SWEDEN SWITZERLAND TAIWAN THAILAND TURKEY UNITED ARAB EMIRATES UNITED KINGDOM
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = OWB and Original Applicant = Medtronic Inc.
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