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U.S. Department of Health and Human Services

Class 2 Device Recall Siemens syngo(R) Lab Data Manager

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  Class 2 Device Recall Siemens syngo(R) Lab Data Manager see related information
Date Initiated by Firm June 07, 2012
Date Posted August 09, 2012
Recall Status1 Terminated 3 on April 01, 2014
Recall Number Z-2173-2012
Recall Event ID 62403
Product Classification Software, transmission and storage, patient data - Product Code NSX
Product Siemens syngo(R) Lab Data Manager.

The syngo(R) Lab Data Manager is classified as a data calculator and processing module for use with In-vitro diagnostic devices. It also provides work flow management as well as remote instrument control to multiple interfaced instruments
Code Information Version VA11B and all previously released versions.
Recalling Firm/
Manufacturer		 Siemens Healthcare Diagnostics, Inc.
500 GBC Drive, Mailstop 514
PO BOX 6101
Newark DE 19714-6101
For Additional Information Contact Customer Support
302-631-0516
Manufacturer Reason
for Recall		 The recalling firm has discovered that when using a Sysmex(R) CA-7000 or CA-1500 coagulation analyzer with the syngo Lab Data Manager (LDM), there is a potential for the syngo LDM system, to display and transmit to the LIS an incorrect result following the syngo LDM's application of the configured result number format. The problem is encountered when the result number format configured on the Sys
FDA Determined
Cause 2		 Software design (manufacturing process)
Action Siemens Healtcare Diagnostics sent a Urgent Field Safety Notice dated June 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were advised to discuss the contents of this letter with your Laboratory Director regarding the need to review any previous test results. If you have any technical questions or concerns, please contact the Seimens Technical Solutions Center at 1-800-441-9250, for further assistance.
Quantity in Commerce 15
Distribution USA (nationwide) including the states of AZ, CA, MS, MO, NJ, NC, OH, OR, PA, and TX.
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.
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