Recall Z-0404-2019 ยท OWB Interventional Fluoroscopic X-Ray System
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
| Date | Sep 17, 2018 |
| Status | Terminated |
| 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 R |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K173664 | Medtronic O-arm O2 Imaging System Medtronic, Inc., Dec 29, 2017 |