FDA recall Z-1040-2026

Mobius Imaging, LLC · Class II · device

Product

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.

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.

Key facts

Status
Ongoing
Initiation date
2025-12-04
Report date
2026-01-21
Voluntary/Mandated
Voluntary: Firm initiated
Location
Shirley, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1040-2026