Device 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.
Z-1195-2019
Product summary
- Event
- Event 82345
- Status
- Terminated
- Classification
- Class II
- Quantity
- 449 systems
- Official record key
device-enforcement:Z-1195-2019
Official wording
Reason: Software Issues.
Code information: Catalog Numbers: 10638933, 10624077, 10804573 510K Exempt
Distribution pattern: Worldwide distribution - US Nationwide and countries of Japan, Germany, Belgium, France, Italy, Slovakia, Bahamas, United Kingdom and Mexico.
Derived failure modes
-
Unknown
Software Issues.