HIGH

Mobius Imaging Recalls AIRO CT X-ray Pendant Due to Safety Risk

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.

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

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

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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

  1. Locate the part number MI-70-0128 on your device.
  2. Check the serial numbers listed against your unit.
  3. 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.

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

  • 26 units recalled
  • Part No. MI-70-0128
  • Distributed nationwide in the US
  • High hazard due to missing safety label
  • Immediate cessation of use recommended

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product TypeComputed Tomography (CT) X-ray System Upgrade
Sold At
Unknown

Product Details

Model Numbers
Part No. MI-70-0128
UDI: (01) 00869346000200 (11)230920 (21) AIRO-XXXX
Serial No. 2232206183
2232206193
2232206203
+15 more
Affected States
ALL
Report Date
January 21, 2026
Recall Status
ACTIVE

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