# FDA recall Z-1195-2019

> **Siemens Healthcare Diagnostics, Inc.** · Class II · device recall initiated 2015-08-26.

## Product

syngo Lab Data Manager System - Product Usage: syngo Lab Data Manager is a clinical system that assists medical laboratory professions with pre-analytic and post-analytic functions. It works in conjunction with multiple instruments, the laboratory information system (LIS) and the Siemens Healthcare Diagnostics Data Center. It supports the Siemens analyzers through delivery of applications and connectivity features.

## Reason for recall

Software Issues.

## Distribution

Worldwide distribution - US Nationwide and countries of Japan, Germany, Belgium, France, Italy, Slovakia, Bahamas, United Kingdom and Mexico.

## Key facts

- **Recall number:** Z-1195-2019
- **Recalling firm:** Siemens Healthcare Diagnostics, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2015-08-26
- **Report date:** 2019-04-24
- **Termination date:** 2020-03-24

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Newark, DE, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1195-2019

## Citation

> AI Analytics. FDA recall Z-1195-2019. Retrieved 2026-07-15 from https://api.ai-analytics.org/recall/Z-1195-2019. Source: US FDA. Licensed CC0.

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