# FDA recall Z-1501-2020

> **Siemens Medical Solutions USA, Inc** · Class II · device recall initiated 2020-02-10.

## Product

Ysio, model no. 10281013    Product Usage: The product is a stationary X-Ray system.

## Reason for recall

The Ysio system may process incorrect internal values for the position of its ceiling tube stand. If in this situation the user activates longitudinal or transversal stand movement (by using the buttons at the tube head or the remote console), the systems controls may (depending on the values being processed) initiate a correction of the tube stand position, resulting in an unexpected movement.

## Distribution

US Nationwide distribution in the states of AR, CA, DC, FL, IA, IL, IN, KS, KY, MA, MD, MI, MN, MO, MS, NC, NE, NH, NJ, NV,   NY, OH, OR, PA, SC, TX, UT, VA and WI.

## Key facts

- **Recall number:** Z-1501-2020
- **Recalling firm:** Siemens Medical Solutions USA, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-02-10
- **Report date:** 2020-03-25
- **Termination date:** 2020-08-31

- **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-1501-2020

## Citation

> AI Analytics. FDA recall Z-1501-2020. Retrieved 2026-06-16 from https://api.ai-analytics.org/recall/Z-1501-2020. Source: US FDA. Licensed CC0.

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