Mobius Imaging recalled 26 units of the Detachable 10in Pendant Upgrade for the AIRO CT X-ray System on December 4, 2025. The devices lack a critical "Safe Hand Position Warning" label, posing a high risk during operation. Healthcare providers and patients must cease use immediately and follow the manufacturer's 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 26 units of the Detachable 10in Pendant Upgrade, Part No. MI-70-0128, distributed across multiple states including CA, NY, and TX. The devices are identified by several serial numbers, including 2232206183 and 2303429503.
The lack of the "Safe Hand Position Warning" label increases the risk of operator injury during use. This recall falls under Class II, indicating a moderate risk of adverse health consequences.
No specific incidents or injuries related to this recall have been reported. However, the absence of safety labeling poses a significant safety concern.
Stop using the affected devices immediately. Contact Mobius Imaging, LLC or your healthcare provider for further instructions on returning the product.
For more information, visit the FDA recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-1041-2026 or reach out to Mobius Imaging directly.
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