Medtronic recalls O-arm 1000 2nd Edition Imaging Systems due to 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 its O-arm 1000 2nd Edition Imaging Systems because software issues could cause problems with starting up, shutting down, communication, motion control, and imaging. This affects medical devices used in surgery for 2D and 3D imaging. The recall requires updating to software version 3.1.7 to fix the issues.
The software anomalies could cause the system to malfunction during startup, shutdown, communication, motion control, image acquisition, and dose reporting. This might lead to incorrect imaging or data, but the recall indicates the issue is fixable with a software update.
Medical professionals using the O-arm 1000 2nd Edition Imaging System for surgical procedures are likely affected. Patients undergoing surgery with this system may be at risk if the software issues cause imaging problems.
Check for the model number 'Bl70000027100' on the system. The product was sold with the serial number starting with 'Bl70000027100' and is used in medical settings for 2D and 3D imaging during surgery.
Install software version 3.1.7 to resolve the software anomalies affecting system functions.
The model number is Bl70000027100.
The software anomalies could cause problems with startup, shutdown, communication, motion control, image acquisition, and dose reporting, which might lead to incorrect imaging or data during procedures.
The recall does not mention a risk of serious injury; the issue is fixable with a software update.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-0273-2019 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-0273-2019 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.
