Medtronic Navigation recalls OARM BI70002000 SYS IMAGING 02 imaging systems for a software update to prevent potential safety issues. Affected units have serial numbers C0875 to C2012.
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
Medtronic Navigation is recalling its OARM BI70002000 SYS IMAGING 02 interventional fluoroscopic x-ray systems. The recall is due to a software update needed to address a safety issue with the system's image acquisition.
The system requires a software update to version 4.1.0 and a new user manual to prevent potential safety issues. The recall also involves replacing a blown fuse in the AC power input circuit.
Healthcare professionals using Medtronic Navigation's OARM BI70002000 SYS IMAGING 02 imaging systems with serial numbers C0875 to C2012 are most at risk.
Check for the model number BI70002000 or BI70002000R on the system. Serial numbers C0875 through C2012 indicate affected units.
Install software version 4.1.0 to address the safety issue.
Replace the blown fuse in the AC power input circuit as specified.
The model numbers are BI70002000 and BI70002000R.
Serial numbers C0875 through C2012 are affected.
Yes, you need to update the software to version 4.1.0 and replace the blown fuse in the AC power input circuit.
We’ve drafted a message you can send Medtronic Navigation to request your refund or repair — edit it as you like.
Subject: Recall Z-0404-2019 — Medtronic Navigation Medtronic Navigation Hello, I own a Medtronic Navigation that is covered by recall Z-0404-2019 from Medtronic Navigation. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
