Mobius Imaging recalled 101 units of the AIRO Computed Tomography X-ray system pendant on December 4, 2025. The pendants lack a critical "Safe Hand Position Warning" label, posing a safety risk for healthcare providers. Users should immediately stop using these devices and follow recall instructions.
AIRO pendant replacement kits and upgrade do not possess the "Safe Hand Position Warning" label.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Mobius Imaging, LLC or your healthcare provider for instructions. Notification method: Letter
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The AIRO Computed Tomography (CT) X-ray System component is used in medical imaging to provide detailed internal views of patients. Healthcare providers rely on this equipment for accurate diagnostics and treatment planning.
The lack of a "Safe Hand Position Warning" label can lead to improper use, increasing the risk of harm to both patients and healthcare providers. This labeling is essential for ensuring safe operation during use.
This recall is not part of a broader industry pattern.
The recall requires immediate action from healthcare providers and could disrupt medical services depending on the availability of compliant replacement components.
Serial numbers can typically be found on the device's label or user manual. Check the manufacturer's website for specific guidance on locating identifiers.
Expect a response regarding the recall instructions within 4-6 weeks.
Keep records of your purchase, including receipts and correspondence with the manufacturer. Document any communications regarding the recall for your records.
The recall affects 101 units of the detachable 10in Pend FRU-1 component for the AIRO Computed Tomography (CT) X-ray System. The affected model numbers include Part No. MI-76-0237 and several serial numbers ranging from 2232206713 to 2311019263. These units were distributed nationwide across various states including California, Texas, and New York.
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