# FDA recall Z-1346-2021

> **Siemens Medical Solutions USA, Inc** · Class II · device recall initiated 2021-03-10.

## Product

Ysio X.pree, Model Number: 11107464 - Product Usage: A Digital  X-Ray System generate Xray images from the whole body including the skull, chest, abdomen, and extremities.

## Reason for recall

A patient image was assigned to a different patient during image recovery process. In the unlikely event of interrupted connection to a MAX detector during initiated image recovery, instead of the currently acquired image, previously acquired image (potentially image of the previous patient) may be displayed to the user, potentially impact diagnosis of the patient examined when the connection was interrupted

## Distribution

US Nationwide distribution in the states of FL, MN, OH, PA, TX.

## Key facts

- **Recall number:** Z-1346-2021
- **Recalling firm:** Siemens Medical Solutions USA, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-03-10
- **Report date:** 2021-04-14
- **Termination date:** 2023-12-11

- **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-1346-2021

## Citation

> AI Analytics. FDA recall Z-1346-2021. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-1346-2021. Source: US FDA. Licensed CC0.

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