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
FDA Recall Z-0404-2019 · Posted None
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Recalling FirmMedtronic Navigation, Inc.-Littleton
Recall StatusTerminated
Product CodeOWB
Date Initiated2018-09-17
Date Terminated2020-05-28
Product Quantity641 units
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
Firm 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.
Root Cause
Software design
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
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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