Quick Facts at a Glance
- Recall Date
- December 4, 2025
- Hazard Level
- HIGH
- Brand
- Mobius Imaging
- Category
- Health & Personal Care
- Sold At
- Unknown
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Mobius Imaging
- Product type
- Computed Tomography (CT) X-ray System Upgrade
- Model numbers
- Part No. MI-70-0128, UDI: (01) 00869346000200 (11)230920 (21) AIRO-XXXX, Serial No. 2232206183, 2232206193, 2232206203, 2232206213, 2232206223, 2232206233 +12 more
- Sold at
- Unknown
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
December 4, 2025
Reported by FDA DEVICE
January 21, 2026
RecallRadar source check
January 28, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
AIRO pendant replacement kits and upgrade do not possess the "Safe Hand Position Warning" label.
What You Should Do
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
About This Product
The Detachable 10in Pendant Upgrade for the AIRO CT X-ray System is designed to enhance the functionality of CT imaging. These devices are typically used in healthcare settings for advanced imaging procedures.
Why This Is Dangerous
Without the "Safe Hand Position Warning" label, operators may inadvertently place their hands in unsafe positions during scans, leading to potential injuries.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The recall could disrupt imaging services in healthcare facilities, requiring immediate attention from medical staff to ensure patient safety.
Practical Guidance
How to identify if yours is affected
- Locate the part number MI-70-0128 on your device.
- Check the serial numbers listed against your unit.
- Contact Mobius Imaging for confirmation if unsure.
Where to find product info
Part numbers and serial numbers are typically located on the product label or packaging.
What timeline to expect
Expect a realistic timeline of 4-6 weeks for refund processing once the device is returned.
If the manufacturer is unresponsive
- Document all communication attempts with Mobius Imaging.
- Reach out to the FDA to report lack of response.
- Consider legal advice if necessary.
How to prevent similar issues
- When purchasing medical devices, ensure they have all necessary safety labels and certifications.
- Research the manufacturer for compliance with safety standards.
- Stay informed about product recalls in the medical device industry.
Documentation advice
Keep records of your purchase, including receipts and correspondence with the manufacturer.
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Product Details
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.
Key Facts
- Part No. MI-70-0128
- Distributed nationwide in the US
- High hazard due to missing safety label
- Immediate cessation of use recommended
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Safety Guide
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