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U.S. Department of Health and Human Services

Class 2 Device Recall Symbia T Series SPECTCT System

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 Class 2 Device Recall Symbia T Series SPECTCT Systemsee related information
Date Initiated by FirmDecember 11, 2009
Date PostedDecember 29, 2009
Recall Status1 Terminated 3 on August 27, 2012
Recall NumberZ-0584-2010
Recall Event ID 53919
510(K)NumberK041166 
Product Classification System, x-ray, tomography, computed - Product Code JAK
ProductSymbia T Series SPECT-CT (Single-Photon Emission Computed Tomography and Computed Tomography) System; Siemens Medical Solutions USA, Inc., Hoffman Estates, IL 60195-2061. Indications for use: SPECT + CT: Perform scans and nuclear imaging studies with the same instrument. To obtain attenuation corrected images and to provide registration of anatomical and physiological images within the patient's anatomy.
Code Information Part: 8717733, Serial Numbers: 1015, 1027, 1037, 1046, 1061, 1065, 1068, 1072, 1074, 1076, 1077, 1078, 1092, 1095, 1102, 1120, 1121, 1122, 1127, 1128, 1131, 1136, 1143, 1145, 1146, 1148, 1151, 1153, 1169, 1171, 1172, 1174, 1175, 1179, 1190 and 1192;  Part: 10275007, Serial Numbers: 1021, 1030, 1034, 1039, 1052, 1060, 1061, 1064, 1065, 1070, 1071, 1074, 1079, 1085, 1091, 1093, 1098;  part 10275008, serial number 1003, 1005, 1011, 1013, 1014, 1015, 1023, 1038, 1039, 1044, 1046, 1056, 1065, 1066, 1068, 1071, 1072, 1076, 1082, 1084, 1094, 1097 and 1105;  Part: 10275009, Serial Numbers: 1003, 1004, 1008, 1009, 1015, 1026, 1027, 1033, 1034, 1037, 1040, 1047, 1053, 1058, 1066 and 1071; and  Part 10275010, Serial Numbers: 1008, 1011, 1018, 1026 and 1029. 
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc.
2501 Barrington Rd
Hoffman Estates IL 60195-2061
For Additional Information ContactMr. Ron Nolte
847-304-7700
Manufacturer Reason
for Recall		Some of the hand controllers of the Symbia S & T systems are missing a resistor switch, and the absence of the switch may lead to unintended system motion during camera set up activities.
FDA Determined
Cause 2		Process control
ActionSiemens issued an Urgent Field Correction Recall letters dated November 18, 2009 and December 11, 2009 to the affected users of the Symbia S and Symbia T Systems, respectivley. The customers were advised of precautionary measures and that Siemens will replace the affected device. They also were advised that a Siemens Customer Service Representative would contact them within a few days to schedule a replacement of the device. For further information, contact Siemens Medical Solutions USA, Inc. at 1-800-888-7436 (USA).
Quantity in Commerce97 units
DistributionWorldwide Distribution -- United States, Algeria, Australia, Austria, Belgium, Canada, Chile, China, Finland, France, Germany, Hong Kong, India, Indonesia, Italy, Korea, Mexico, Netherlands, Norway, Philippines, Portugal, Qatar, Russia, Saudi Arabia, Spain, Sweden, Taiwan, Turkey, Venezuela and Vietnam.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = JAK
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