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U.S. Department of Health and Human Services

Class 2 Device Recall Siemens syngo(R) Lab Data Manager Version VA11B and VA12A

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  Class 2 Device Recall Siemens syngo(R) Lab Data Manager Version VA11B and VA12A see related information
Date Initiated by Firm May 10, 2013
Date Posted December 03, 2013
Recall Status1 Terminated 3 on August 26, 2014
Recall Number Z-0433-2014
Recall Event ID 65147
Product Classification Software, transmission and storage, patient data - Product Code NSX
Product syngo(R) Lab Data Manager - Version VA11B and VA12A Systems

Securely consolidates data from multiple lab instruments, the LIS and Siemens StreamLAB(R) Automation Solutions. It provides autoverification, integrated QC capabilities, browser-based connectivity supporting up to 25 concurrent users, remote services to help keep systems running optimally and also has audit trail capabilities.
Code Information Siemens Material Number 10800057 (Version VA11B) and 10803188 (Version VA12A)
Recalling Firm/
Manufacturer		 Siemens Healthcare Diagnostics, Inc.
500 Gbc Dr Ms 514
PO BOX 6101
Newark DE 19702-2466
For Additional Information Contact Customer Support
800-441-9250
Manufacturer Reason
for Recall		 Under certain conditions the system may not perform as intended, causing the release of results to the Laboratory Information System that should have been held for manual review due to auto-verification rules or the delay/omission of result transmission to the LIS.
FDA Determined
Cause 2		 Software design
Action Siemens sent an Urgent Medical Device Correction letter in May 2013 to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to review the letter in its entirety and ensure that all operators understand the information presented. Specific actions needed to be implemented by the customer were outlined in the letter. Customers were instructed to retain the letter with their laboratory records, and forward the letter to those who may have received the affected product. Customers with questions were instructed to contact their Siemens Technical Solutions Center or their local Siemens technical support representative. For questions regarding this recall call 800-441-9250.
Quantity in Commerce 262
Distribution Worldwide Distribution: USA (nationwide) and internationally to Canada.
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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