Mobius Imaging, LLC: Device Recall
Recall #Z-1040-2026 · 12/04/2025
Class II: Risk
Recall Details
- Recall Number
- Z-1040-2026
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Mobius Imaging, LLC
- Status
- Ongoing
- Date Initiated
- 12/04/2025
- Location
- Shirley, MA, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 101 units
Reason for Recall
AIRO pendant replacement kits and upgrade do not possess the "Safe Hand Position Warning" label.
Product Description
Detachable 10in Pend FRU-1 Pend component for the AIRO Computed Tomography (CT) X-ray System.
Distribution Pattern
US Nationwide distribution in the states of AK, AL, AZ, CA, CO, CT, DC, FL, IL, KY, MA, MD, MI, MN, MO, NC, NY, OH, PA, RI, SC, TN, TX, UT, VA, WI.
Other Recalls by Mobius Imaging, LLC
- Class II: Risk 12/04/2025
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.