# FDA recall Z-0730-2022

> **Siemens Medical Solutions USA, Inc** · Class II · device recall initiated 2022-03-07.

## Product

YSIO X.Pree

## Reason for recall

For the automated multi-image-acquisition procedure Ortho x-ray collimation is set in a preparative stage for the entire examination area prior to the exam. During acquisition of each individual x-ray image, the x-ray collimator is automatically positioned in a way that the subsequent series of acquisition covers the defined field of view needed for each step. However, during the acquisition the collimation area displayed to the operator on the User Interface does not correctly represent the collimation area specified by the system. It indicates to the user an open collimator instead, e.g., the information displayed on the User Interface shows wider area of collimation than values preset prior to the examination. However, the collimation of the x-ray is performed correctly and always matches the examination area predefined by the user.

## Distribution

US Nationwide, Worldwide distribution

## Key facts

- **Recall number:** Z-0730-2022
- **Recalling firm:** Siemens Medical Solutions USA, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-03-07
- **Report date:** 2022-04-13

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0730-2022

## Citation

> AI Analytics. FDA recall Z-0730-2022. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-0730-2022. Source: US FDA. Licensed CC0.

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