Medtronic recalls O-arm 1000 2nd Edition Imaging Systems with software anomalies affecting startup, shutdown, communication, motion control, and image acquisition. Software update 3.1.7 will fix these issues.
Software anomalies were reported to affect the following system functionalities: startup and shutdown, system and network communication, motion control, image acquisition and output, dose reporting, and logs generation. Software version 3.1.7 will be installed on all 2nd edition imaging systems.
Medtronic is recalling O-arm 1000 2nd Edition Imaging Systems due to software anomalies that could affect startup, shutdown, communication, motion control, image acquisition, and output. This recall is important because the software issues might lead to improper functioning of the system during medical procedures.
The software anomalies could cause issues with the system starting up or shutting down, communication between components, motion control, image acquisition, and output. This might lead to improper imaging during medical procedures if not corrected.
Healthcare facilities using the O-arm 1000 2nd Edition Imaging System with model number Bl70000027GER are affected. Medical staff and patients using this system for imaging procedures are at risk.
Check for the model number Bl70000027GER on the O-arm 1000 2nd Edition Imaging System. The product was sold with all serial numbers and is used in medical facilities for 2D and 3D imaging procedures.
Medtronic will provide software version 3.1.7 to fix the reported software anomalies.
The recall addresses software anomalies that could affect system functions, but the risk is low as the software update resolves the issues.
Contact Medtronic to install software version 3.1.7, which will fix the software anomalies.
Check for the model number Bl70000027GER on the O-arm 1000 2nd Edition Imaging System.
We’ve drafted a message you can send Medtronic Navigation to request your refund or repair — edit it as you like.
Subject: Recall Z-0279-2019 — Medtronic Navigation Medtronic Navigation Hello, I own a Medtronic Navigation that is covered by recall Z-0279-2019 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.
