# FDA recall Z-1339-2020

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

## Product

Ysio Max, model no. 10762470 - Product Usage: The Ysio Max is a radiographic system used in hospitals, clinics, and medical practices. Ysio Max enables radiographic and tomographic exposures f the whole body including: skull, chest, abdomen, and extremities and may be used on pediatric, adult and bariatric patients. It can also be used for intravenous, small interventions (like biopsy, punctures, etc.) and emergency (trauma, critical ill) applications. Exposures may be taken with the patient sitting, standing, or in the prone position. The Ysio max system is not meant for mammography.

## Reason for recall

A software bug may lead to one image to be assigned to two different patients, which could potentially affect medical diagnosis.

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-1339-2020
- **Recalling firm:** Siemens Medical Solutions USA, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-01-08
- **Report date:** 2020-02-26
- **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-1339-2020

## Citation

> AI Analytics. FDA recall Z-1339-2020. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1339-2020. Source: US FDA. Licensed CC0.

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