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.
Reported: April 24, 2019 Initiated: August 26, 2015 #Z-1195-2019
Product Description
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.
Details
- Recalling Firm
- Siemens Healthcare Diagnostics, Inc.
- Units Affected
- 449 systems
- Distribution
- Worldwide distribution - US Nationwide and countries of Japan, Germany, Belgium, France, Italy, Slovakia, Bahamas, United Kingdom and Mexico.
- Location
- Newark, DE
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Siemens Healthcare Diagnostics, Inc.. Units affected: 449 systems.
Why was this product recalled? ▼
Software Issues.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 24, 2019. Severity: Moderate. Recall number: Z-1195-2019.
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