Z-0404-2019Class II

Medtronic Navigation 0-arm 02 Imaging System interventional fluoroscopic x-ray system: OARM BI70002000 SYS...

Name: Z-0404-2019 Medtronic Navigation 0-arm 02 Imaging System interventional fluoroscopic x-ray system: OARM BI70002000 SYS...
Creator: Medtronic Navigation, Inc.-Littleton
Published: 2018-09-17
License: https://open.fda.gov/license/

Medtronic Navigation, Inc / initiated 2018-09-17 / Terminated / root cause: software

FDA source

Medtronic Navigation, Inc.-Littleton began a recall of Medtronic Navigation 0-arm 02 Imaging System interventional fluoroscopic x-ray system: OARM BI70002000 SYS IMAGING 02 Model: BI70002000 OARM BI70002000R SYS... on 2018-09-17. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0404-2019
Classification: Class II
Status: Terminated
Initiated: 2018-09-17
Posted: 2018-11-07
Terminated: 2020-05-28
Recalling firm: Medtronic Navigation, Inc
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
Product code: OWB Interventional Fluoroscopic X-Ray System
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
Root cause tag: software
FDA root cause: 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
Product codes and lots: Serial Numbers:C0875 through C2012

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0404-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0404-2019	Class II	Terminated	Voluntary: Firm initiated	2018-11-14	2018-11-07

Product code OWB

K173664Class IIMedtronic O-arm O2 Imaging SystemMedtronic, Inc. / cleared 2017-12-29

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)