Recall Z-1195-2019— Siemens Healthcare Diagnostics, Inc.
Class II · Terminated
Class II FDA medical device recall by Siemens Healthcare Diagnostics, Inc., initiated 2015-08-26, terminated 2020-03-24. FDA's recall record names no specific 510(k) clearance for this event. 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: Software Issues..
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-08-26
- Terminated
- 2020-03-24
- Firm location
- Newark, DE, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.