Medtronic recalls O-arm 1000 2nd Edition Imaging Systems with software anomalies affecting startup, shutdown, communication, motion control, and imaging functions. Update to software version 3.1.7 resolves the issue.
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, and imaging functions. This recall requires updating to software version 3.1.7 to fix the issues.
Software anomalies in the system could cause improper startup, shutdown, communication failures, motion control issues, and incorrect imaging outputs. These problems might lead to inaccurate medical imaging if not corrected.
Healthcare professionals using the O-arm 1000 2nd Edition Imaging System for medical procedures are affected. The risk is low as the issue requires a software update rather than immediate physical danger.
The product includes the model number Bl70000027230R and is sold as the O-arm 1000 2nd Edition Imaging System. All units with this model number are affected.
Install software version 3.1.7 to resolve the software anomalies affecting system functions.
The model number is Bl70000027230R.
All O-arm 1000 2nd Edition Imaging Systems with model number Bl70000027230R are affected.
Install software version 3.1.7 to fix the software anomalies.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-0278-2019 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-0278-2019 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.
