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Siemens Healthcare Diagnostics, Inc. recalls syngo Lab Data Manager System - Product Usage: syngo Lab Data Manager is a clinical system that assists medical laborato
Recalled April 24, 2019 · FDA recall Z-1195-2019 · Siemens Healthcare Diagnostics
Hazard
Software Issues. · FDA Class II
Units
449 systems
Sold at
Worldwide distribution - US Nationwide and countries of Japan, Germany, Belgium, France, Italy, Slovakia, Bahamas, United Kingdom and Mexico.
Description
Software Issues.
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.
Manufacturer(s)
Siemens Healthcare Diagnostics, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →