# FDA recall Z-2283-2018

> **Siemens Medical Solutions USA, Inc** · Class II · device recall initiated 2018-05-01.

## Product

ARTIS Pheno Interventional Fluoroscopic X-Ray System, Model 10849000

## Reason for recall

If the C-arm is manually moved in the longitudinal direction to a fully extended position, the system's safety stop mechanism may be activated. As a result, the C-arm stops the movement and can drop up to 20 mm (0.8 ). Under certain circumstances, the cover of the detector or collimator can touch and possibly injure the patient due to the C-arm drop. This could lead to a situation in which it is necessary to stop the clinical treatment or continue the treatment on an alternative system.

## Distribution

Healthcare facilities in AL, CA, CO, FL, IL, KY, MA, MI, MN, MS, NE, NJ, NY, OH, TN, TX, UT, and VA. Foreign distribution to Australia, Austria, Belgium, Denmark, France, Germany, Italy, Japan, Kuwait, Netherlands, Norway, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, and United Kingdom.

## Key facts

- **Recall number:** Z-2283-2018
- **Recalling firm:** Siemens Medical Solutions USA, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Completed
- **Initiation date:** 2018-05-01
- **Report date:** 2018-07-04
- **Termination date:** 2020-03-18

- **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-2283-2018

## Citation

> AI Analytics. FDA recall Z-2283-2018. Retrieved 2026-05-27 from https://api.ai-analytics.org/recall/Z-2283-2018. Source: US FDA. Licensed CC0.

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