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U.S. Department of Health and Human Services

Class 2 Device Recall Syngo Imagaing

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 Class 2 Recall
Syngo Imagaing
see related information
Date Posted October 15, 2008
Recall Status1 Terminated on November 19, 2008
Recall Number Z-0102-2009
Recall Event ID 49496
Premarket Notification
510(K) Numbers
K052461  K071114 
Product Classification System, Image Processing, Radiological - Product Code LLZ
Product Syngo Imaging with versions VB20B, VB20D, VB20F, VB20G, VB25B, VB30A, VB30A_SP1, and VB30A_SP2.
Code Information Model number 10014063. Serial numbers: 1005, 1039, 1040, 1041, 1049, 1053, 1055, 1056, 1057, 1058, 1061, 1064, 1065, 1067, 1071, 1074, 1076, 1079, 1080, 1081, 1082, 1083, 1084, 1086, 1089, 1090, 1095, 1105, 1107, 1112, 1116, 1119, 1124, 1174, 1188, 1198, 1202, 1203, 1210, 1218, 1226, 1227, 1229, 1240, 1246, 1247, 1258, 1269, 1271, 1278, 1279, 1282, 1316, 1322, 1329, 1334, 1343, 1351, and 1353.
Recalling Firm/
Manufacturer
Siemens Medical Solutions USA, Inc
51 Valley Stream Pkwy
Malvern, Pennsylvania 19355
For Additional Information Contact Rita Intorella
201-831-5825
Manufacturer Reason
for Recall
Image may not be visible after merge.
FDA Determined
Cause 2
DESIGN: Software Design (Manufacturing Process)
Action The recalling firm issued Customer Safety Advisory Notice dated 8/22/08 to inform the consignees of the potential issue and provide instruction to avoid its occurrence. To avoid potential risk of this issue, users are asked to check whether the extended HL7 messages as stated in the letter are mandatory for their RIS-PACS workflow, and disable these messages if they are not. Siemens is preparing a modification under the UI IM086/08/S for the affected versions of syngo Imaging that will resolve the potential malfunction. The field modification will be immediately distributed and installed by the firm's Service as soon as it is available.
Quantity in Commerce 59 units
Distribution Nationwide Distribution --- including states of AL, AZ, CA, CO, CT, FL, IA, KS, LA, MA, MD, MI, MN, MO, NC, NE, NJ, NY, OH, OK, OR, PA, TN, TX, and WI.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = LLZ and Original Applicant = SIEMENS AG, MEDICAL SOLUTIONS
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