Medtronic recalls O-arm 1000 mobile x-ray systems with specific model numbers for software update to fix power shutdown and image reconstruction problems.
Software update ("SW Update 3.2.1") is being implemented to address the following issues: Inability to power the system after shutdown, System stays in standalone mode, Image reconstruction, System/Pendant bootup, Dose display/report, Gantry motion, Network communication, System shutdown, and Early termination of 3D spin.
Medtronic is recalling certain O-arm 1000 mobile x-ray systems due to software issues that can cause the system to not power up after shutdown or fail to reconstruct images properly. This affects medical imaging equipment used in surgeries.
The software update addresses issues where the system may not power up after shutdown, stay in standalone mode, fail to reconstruct images, or have problems with bootup and shutdown processes. These issues could disrupt surgical imaging procedures but do not pose immediate safety risks.
Healthcare facilities using the O-arm 1000 mobile x-ray systems with the listed model numbers and serials are most at risk. These systems are used for surgical imaging in hospitals and clinics.
Check for model numbers starting with BASE OARM Bl70000028100 SYS 100V, Bl70000028120 SYS 120V, or Bl70000028230 SYS 230V. The product serial numbers listed in the recall notice include specific combinations of numbers and letters.
Verify your system's software version to confirm if it needs the SW Update 3.2.1 fix.
No, the recall requires a software update, not immediate discontinuation. You can continue using the system after applying the update.
The SW Update 3.2.1 fixes issues with powering up after shutdown, image reconstruction, and system bootup processes.
Check your model number and serial number against the list provided in the recall notice.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-0928-2018 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-0928-2018 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.
