Detachable 10in Pend FRU-1 Pend component for the AIRO Computed Tomography (CT) X-ray System.
Reported: January 21, 2026 Initiated: December 4, 2025 #Z-1040-2026
Product Description
Detachable 10in Pend FRU-1 Pend component for the AIRO Computed Tomography (CT) X-ray System.
Reason for Recall
AIRO pendant replacement kits and upgrade do not possess the "Safe Hand Position Warning" label.
Details
- Recalling Firm
- Mobius Imaging, LLC
- Units Affected
- 101 units
- Distribution
- 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.
- Location
- Shirley, MA
Frequently Asked Questions
What product was recalled? ▼
Detachable 10in Pend FRU-1 Pend component for the AIRO Computed Tomography (CT) X-ray System.. Recalled by Mobius Imaging, LLC. Units affected: 101 units.
Why was this product recalled? ▼
AIRO pendant replacement kits and upgrade do not possess the "Safe Hand Position Warning" label.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 21, 2026. Severity: Moderate. Recall number: Z-1040-2026.
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