Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall syngo Lab Data Manager System

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall syngo Lab Data Manager System see related information
Date Initiated by Firm August 26, 2015
Create Date April 18, 2019
Recall Status1 Terminated 3 on March 24, 2020
Recall Number Z-1195-2019
Recall Event ID 82345
Product Classification Calculator/data processing module, for clinical use - Product Code JQP
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.
Code Information Catalog Numbers: 10638933, 10624077, 10804573 510K Exempt 
Recalling Firm/
Manufacturer		 Siemens Healthcare Diagnostics, Inc.
500 Gbc Dr Ms 514
Newark DE 19702-2466
For Additional Information Contact
800-441-9250
Manufacturer Reason
for Recall		 Software Issues.
FDA Determined
Cause 2		 Device Design
Action Siemens mailed an Urgent Field Safety Notice and an Urgent Field Correction Letter to affected customers on 08/26/2015 to inform them of the issue. The reason for the correction, risk to health and actions to be taken were explained in the notice.
Quantity in Commerce 449 systems
Distribution Worldwide distribution - US Nationwide and countries of Japan, Germany, Belgium, France, Italy, Slovakia, Bahamas, United Kingdom and Mexico.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
-
-