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U.S. Department of Health and Human Services

Class 2 Device Recall Syngo Imaging XS

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  Class 2 Device Recall Syngo Imaging XS see related information
Date Initiated by Firm September 29, 2009
Date Posted November 16, 2009
Recall Status1 Terminated 3 on July 05, 2012
Recall Number Z-0271-2010
Recall Event ID 53563
510(K)Number K082430  
Product Classification Picture archiving and communications system. - Product Code LLZ
Product Syngo Imaging XS VA60 and VA70 in combination with JPEG Compression
Code Information Model number 10496279 - Serial numbers: 1088, 1089, 1150, 1165, 1166, 1213, 1214, 1344, 1361, 1371, 1372, 1373, 1374, 1375, 1376, 1377, 1378, 1379, 1380, 1381, 1382, 1383, 1395, 1413, 1418, 1424, 1425, 1453, 1496, and 1497.
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
51 Valley Stream Pkwy
Malvern PA 19355
For Additional Information Contact Customer Service
610-219-6300
Manufacturer Reason
for Recall		 Distorted image. The "Distorted" image cannot be used for diagnostic findings, and, depending on the customer scenario, a repeated exam could be necessary if the image cannot be reported on any other workplace or recovered from another source.
FDA Determined
Cause 2		 Software design
Action The recalling firm issued a Customer Safety Advisory notice dated 9/14/09 to all affected customers via Update Instructions IM100/09/S. The notice informs the customer of the potential issue and provides instructions to avoid its occurrence. To avoid the potential risk of the issue, the local compression function can be disabled as described in the letter. Depending on the image data, the disabling of compression will result in increased storage usage. The issue will be resolved in the release of version VA70B. For all potentially affected customers with "JPEG Compression" license an update instruction will be released which defines the necessary corrective actions in case of "Distorted" images. The update instruction will be performed on request by the customer service group. Further questions regarding this issue are directed to the local SIEMENS Uptime Service Center or +49 (9131) 84-2056.
Quantity in Commerce 30 units
Distribution The product was shipped to medical facilities in CA, FL, GA, IL, MD, MI, MO, NE, NC, NY, OH, PA, TN, TX, 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.
510(K) Database 510(K)s with Product Code = LLZ and Original Applicant = SIEMENS AG, MEDICAL SOLUTIONS
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