# FDA recall Z-2758-2020

> **Siemens Medical Solutions USA, Inc** · Class II · device recall initiated 2020-01-08.

## Product

SIEMENS Healthineers Ysio Max - Interventional Fluoroscopic X-Ray System, Model:  10762470 - Product Usage: is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image.

## Reason for recall

Two software issues (1) Using the override function in case of blocked system movements affecting Luminos dRF Max, Luminos Agile Max and Uroskop Omnia Max systems may cause collision of the system under operator control with obstacles or persons .(2) Incorrectly assigned image affecting Ysio Max, Luminos dRF Max and Luminos Agile Max systems with detector MAX Static causing incorrect base for diagnosis

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-2758-2020
- **Recalling firm:** Siemens Medical Solutions USA, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-01-08
- **Report date:** 2020-08-12
- **Termination date:** 2022-06-21

- **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-2758-2020

## Citation

> AI Analytics. FDA recall Z-2758-2020. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-2758-2020. Source: US FDA. Licensed CC0.

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