FDA Medical Device Recalls (openFDA)
Medtronic Navigation, Inc.-Littleton: 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
- Recall number
- Z-0404-2019
- Recalling firm
- Medtronic Navigation, Inc.-Littleton
- 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
- Status
- Terminated
- Initiated
- 2018-09-17
- Posted
- not on file
- Terminated
- 2020-05-28
- Reason
- 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
- 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
- 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
- Lot, serial or model codes
- Serial Numbers:C0875 through C2012
- 510(k) numbers
- ["K173664"]
- PMA numbers
- not on file
- Product code
- OWB
- Firm FEI
- 3004785967
- Firm city
- Littleton
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28