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U.S. Department of Health and Human Services

Class 2 Device Recall syngo(R) Lab Data Manager and syngo(R) Lab Process Manager, all versions.

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  Class 2 Device Recall syngo(R) Lab Data Manager and syngo(R) Lab Process Manager, all versions. see related information
Date Initiated by Firm May 29, 2012
Date Posted August 31, 2012
Recall Status1 Terminated 3 on April 10, 2014
Recall Number Z-2305-2012
Recall Event ID 62709
Product Classification Calculator/data processing module for clinical use - Product Code JQP
Product syngo(R) Lab Data Manager and syngo(R) Lab Process Manager, all versions.

This device 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 Robert J. King
302-631-0516
Manufacturer Reason
for Recall		 When using the syngo Quality Control package the system may not perform as intended for Multi-Rule QC violation [e.g., 2(2S), 4(1s) and 10x], unless configured using the instructions on page 2 of the recall notification. QC status may not be flagged appropriately. If auto-verification rules are defined to hold patient results when QC status is out, the patient results will not be held as expecte
FDA Determined
Cause 2		 Software design
Action Siemens sent a Urgent Field Safety Notice letter dated May, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The letter instructed the customers to re-set the Multi-Rule option and instructions are provided on how to do so. This recall notification also included a Field Safety Effectiveness check form to please fax to the Siemens Technical Solutions Center at 302-631-8467 BY June 15th.
Quantity in Commerce 44
Distribution USA ( nationwide ) including the states of AZ, CA, FL, IL, KY, MD, MA, MN, MS, MO, NE, NH, NJ, NY, NC, OH, PA, TX, VA and WV.
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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