Home / Recalls / Medtronic Navigation, Inc.-Littleton / Z-0404-2019

Z-0404-2019 Class II Terminated

Recalled by Medtronic Navigation, Inc.-Littleton — Littleton, MA

FDA device recall Z-0404-2019 was initiated by Medtronic Navigation, Inc.-Littleton on September 17, 2018 and is designated Class II. 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 circ… The recall status is terminated (terminated May 28, 2020). Affected quantity: 641 units.

Recall Details

Product Type: Devices
Report Date: November 14, 2018
Initiation Date: September 17, 2018
Termination Date: May 28, 2020
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 641 units

Product Description

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

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

Distribution Pattern

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

Code Information

Serial Numbers:C0875 through C2012

Other recalls by Medtronic Navigation, Inc.-Littleton

Z-2026-2024 Class II — O-arm O2 Imaging System-Mobile x-ray system designed for 2D fluoroscopic and 3D (April 26, 2024)
Z-2449-2023 Class II — The O-arm O2 Imaging System is a mobile x-ray system designed for 2D fluoroscopi (July 25, 2023)
Z-0767-2020 Class II — O-arm" O2 Imaging System, Product Number/CFN: BI-700-02000 (November 15, 2019)
Z-1932-2019 Class II — Medtronic 0-arm TM 1000 Imaging Systems: Bl-700-00027-XXX and B1-700-00028-XXX ( (May 1, 2019)
Z-0278-2019 Class II — O-arm 1000 2nd Edition Imaging System, BASE OARM Bl70000027230R SYSTEM 230V RWK, (August 30, 2018)
Z-0277-2019 Class II — O-arm 1000 2nd Edition Imaging System, BASE OARM Bl70000027230 SYSTEM 230V, Mode (August 30, 2018)
Z-0272-2019 Class II — O-arm 1000 2nd Edition Imaging System, OARM ASSY Bl70000027R SYS PRODUCT RWK, Mo (August 30, 2018)
Z-0271-2019 Class II — O-arm 1000 2nd Edition Imaging System, OARM ASSY Bl70000027 SYSTEM PRODUCT, Mode (August 30, 2018)
Z-0280-2019 Class II — O-arm 1000 2nd Edition Imaging System, OARM ASSY Bl70000027GERR SYS PRODUCT REFU (August 30, 2018)
Z-0275-2019 Class II — O-arm 1000 2nd Edition Imaging System, BASE OARM Bl70000027120 SYSTEM 120V, Mode (August 30, 2018)