Medtronic recalls O-arm 1000 2nd Edition Imaging Systems due to software issues affecting startup, shutdown, communication, motion control, and image acquisition. Update to software version 3.1.7 resolves the problem.
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 its O-arm 1000 2nd Edition Imaging Systems because software anomalies could cause issues with startup, shutdown, communication, motion control, and image acquisition. This affects medical imaging systems used in surgery. Updating to software version 3.1.7 fixes the problem.
Software anomalies in the system could cause problems with startup, shutdown, communication, motion control, image acquisition, and output. This might lead to inaccurate imaging or system failures during surgery, but the recall indicates the issue is corrected with a software update.
Medical professionals using the O-arm 1000 2nd Edition Imaging System for surgery. Patients undergoing procedures with this system may be at risk if the software issues affect imaging quality.
The O-arm 1000 2nd Edition Imaging System with model number Bl70000027120 and serial numbers listed in the recall notice. This system is used for 2D and 3D medical imaging in surgical settings.
Install software version 3.1.7 to resolve the reported software anomalies.
The recall addresses software anomalies that could affect system functions, but the hazard level is low risk as the issue is corrected with a software update.
Check if your O-arm 1000 2nd Edition Imaging System has model number Bl70000027120 and is used for medical imaging in surgical settings.
Install software version 3.1.7 to fix the software anomalies. No immediate action is needed beyond the update.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-0275-2019 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-0275-2019 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.
