Medtronic recalls O-arm 1000 2nd Edition Imaging Systems with software anomalies affecting startup, shutdown, and imaging functions. Update to software version 3.1.7 resolves 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, and imaging functions. This update prevents potential issues with system communication and image acquisition.
Software anomalies could cause problems with the system starting up, shutting down, communicating with networks, controlling motion, acquiring images, reporting doses, or generating logs. These issues might lead to inconsistent imaging results during procedures.
Medical professionals using the O-arm 1000 2nd Edition Imaging System for surgical procedures. Patients undergoing imaging procedures with this system may be affected.
The product has a model number starting with Bl70000027GERR. It was sold as a refurbished O-arm 1000 2nd Edition Imaging System with serial numbers listed in the recall notice.
Install software version 3.1.7 to fix the reported software anomalies affecting system functions.
The recall addresses software anomalies that could affect system functions, but no serious injury risk is mentioned. The update resolves the issues.
Check if your O-arm 1000 2nd Edition Imaging System has a model number starting with Bl70000027GERR.
Install software version 3.1.7 to fix the software anomalies. No immediate action is needed beyond this update.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-0280-2019 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-0280-2019 from Medtronic. 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.