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 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.
The absence of the "Safe Hand Position Warning" label increases the risk of improper use, which can lead to serious injuries. This recall falls under Class II, indicating a potential for temporary or medically reversible consequences.
No specific incidents have been reported in connection with this recall. However, the lack of safety labeling raises concerns among healthcare providers.
Stop using the affected pendants immediately. Follow the recall instructions provided by Mobius Imaging and contact your healthcare provider for further guidance.
For more information, contact Mobius Imaging, LLC directly or visit the FDA website. You can also follow up using the recall link: https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-1040-2026.
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