# FDA recall Z-1041-2026

> **Mobius Imaging, LLC** · Class II · device recall initiated 2025-12-04.

## Product

Detachable 10in Pendant Upgrade 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

- **Recall number:** Z-1041-2026
- **Recalling firm:** Mobius Imaging, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-12-04
- **Report date:** 2026-01-21

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Shirley, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1041-2026

## Citation

> AI Analytics. FDA recall Z-1041-2026. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-1041-2026. Source: US FDA. Licensed CC0.

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