Date Initiated by Firm |
September 17, 2018 |
Create Date |
November 07, 2018 |
Recall Status1 |
Terminated 3 on May 28, 2020 |
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 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.
|