Mobius Imaging recalls Detachable 10in Pend FRU-1 components for AIRO CT X-ray systems due to missing "Safe Hand Position Warning" label. Affected units have specific serial numbers.
AIRO pendant replacement kits and upgrade do not possess the "Safe Hand Position Warning" label.
Mobius Imaging is recalling Detachable 10in Pend FRU-1 components for AIRO CT X-ray systems because these parts lack a required safety label. This could lead to improper hand positioning during use, potentially causing injury.
The missing "Safe Hand Position Warning" label means users might not know how to position their hands safely when operating the component. This could lead to improper handling and potential injury during medical procedures.
Healthcare facilities using AIRO CT X-ray systems with the specific serial numbers listed in the recall. Medical staff handling these components are most at risk.
Check if your AIRO CT X-ray system has the Detachable 10in Pend FRU-1 component with serial numbers listed in the recall (e.g., 2232206713, 2232206723, etc.).
Look for the "Safe Hand Position Warning" label on the component. If missing, it is part of the recall.
The component lacks the required "Safe Hand Position Warning" label, which could lead to improper hand positioning during use and potential injury.
Check if your component has the missing label. If it does not, it is part of the recall and you should contact Mobius Imaging for guidance.
Yes, the recall includes specific serial numbers listed in the record, such as 2232206713, 2232206723, and others.
We’ve drafted a message you can send Mobius Imaging to request your refund or repair — edit it as you like.
Subject: Recall Z-1040-2026 — Mobius Imaging Mobius Imaging Hello, I own a Mobius Imaging that is covered by recall Z-1040-2026 from Mobius Imaging. 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.
