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U.S. Department of Health and Human Services

Class 2 Device Recall Syngo Imagaing

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  Class 2 Device Recall Syngo Imagaing see related information
Date Initiated by Firm November 27, 2007
Date Posted February 23, 2008
Recall Status1 Terminated 3 on September 17, 2008
Recall Number Z-0732-2008
Recall Event ID 46318
510(K)Number K071114  
Product Classification Radiological Image Processing System - Product Code LLZ
Product Siemens Syngo Imaging System with VB30A version of software. Model Number: 10014063, Siemans Medical Solutions, Malvern, PA 19355
Code Information Serial Numbers: 1005, 1065, 1076, 1112, 1202, 1242, 1269, 1278, 1279, and 1282.
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
51 Valley Stream Pkwy
Malvern PA 19355-1406
For Additional Information Contact Catherine Moffa
610-448-1774
Manufacturer Reason
for Recall		 Inconsistent data - A buffer overflow may occur between information system and picture system if the system experiences a high load. (e.g. RIS/PACS communication is unusally high)
FDA Determined
Cause 2		 Software design
Action The recalling firm issued a Customer Safety Advisory, via certified mail. to the affected customers on 11/27/07. The letter informs the customer of the issue and also provides instruction to detect and avoid its occurrence. In addition, the firm is developing a software update to correct the issue, which will be installed on the affected systems when it is released.
Quantity in Commerce 10 units
Distribution Nationwide Distribution, including states of AL, MO, NC, NY, OH, OR, TN, 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.
510(K) Database 510(K)s with Product Code = LLZ and Original Applicant = SIEMENS AG, MEDICAL SOLUTIONS
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