# FDA recall Z-2524-2018

> **Siemens Medical Solutions USA, Inc** · Class II · device recall initiated 2018-05-30.

## Product

ARTIS Pheno, Fluoroscopic X-Ray system, Model Number 10849000

## Reason for recall

During manual LAO/RAO rotation at maximum speed or a combination of LAO/RAO and Cran/Caud rotation at maximum speed, the possibility exists for the safety monitoring within the system control to become activated. As a result, the C-arm stops the rotation and can drop up to 40 mm (1.6 ).

## Distribution

The devices were distributed to the following US states:  AL, CA, CO, FL, IL, KY, MA, MI, MN, MS, ME, NJ, NY, OH, TN, TX, UT, and VA.

## Key facts

- **Recall number:** Z-2524-2018
- **Recalling firm:** Siemens Medical Solutions USA, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-05-30
- **Report date:** 2018-08-01
- **Termination date:** 2020-02-14

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Malvern, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2524-2018

## Citation

> AI Analytics. FDA recall Z-2524-2018. Retrieved 2026-06-16 from https://api.ai-analytics.org/recall/Z-2524-2018. Source: US FDA. Licensed CC0.

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