# FDA recall Z-0957-2023

> **Mobius Imaging, LLC** · Class II · device recall initiated 2022-12-07.

## Product

MobiCT-32 AIRO Mobile CT Scanner, Cat. No. MobiCT-32, mobile computed tomography system.

## Reason for recall

Stryker received one report of an injury to an untrained user that occurred while the untrained user was moving an Airo TruCT unit in reverse. The firm will increase visibility of instructions for users to consider when transporting the unit in reverse by providing labels to be affixed onto the AIRO.

## Distribution

Worldwide distribution - US Nationwide and the countries of Algeria, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Chinese Taipei, Denmark,  Egypt, France, Germany, India, Italy, Japan, Kazakhstan, Korea, Republic of Kuwait,  Lithuania, Malaysia, Mexico, Morocco, Nepal, Netherlands, Norway, Pakistan, Poland,  Russian Federation, Saudi Arabia, Spain, Switzerland, Turkey, United Arab Emirates,  United Kingdom, Viet Nam.

## Key facts

- **Recall number:** Z-0957-2023
- **Recalling firm:** Mobius Imaging, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-12-07
- **Report date:** 2023-01-25

- **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-0957-2023

## Citation

> AI Analytics. FDA recall Z-0957-2023. Retrieved 2026-08-18 from https://api.ai-analytics.org/recall/Z-0957-2023. Source: US FDA. Licensed CC0.

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