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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 FirmSeptember 17, 2018
Create DateNovember 07, 2018
Recall Status1 Terminated 3 on May 28, 2020
Recall NumberZ-0404-2019
Recall Event ID 81355
510(K)NumberK173664 
Product Classification Interventional fluoroscopic x-ray system - Product Code OWB
ProductMedtronic 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
FEI Number 3004785967
Recalling Firm/
Manufacturer		 Medtronic Navigation, Inc.-Littleton
300 Foster St
Littleton MA 01460-2017
For Additional Information ContactSAME
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
ActionMedtronic 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 Commerce641 units
DistributionWorldwide 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 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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