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U.S. Department of Health and Human Services

Class 2 Device Recall Symbia T Series SPECT System

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 Class 2 Recall
Symbia T Series SPECT System
see related information
Date Posted July 07, 2009
Recall Status1 Terminated on September 11, 2010
Recall Number Z-1649-2009
Recall Event ID 51483
Premarket Notification
510(K) Number
K041166 
Product Classification System, Tomography, Computed, Emission - Product Code KPS
Product Siemens Medical Solutions USA, Inc., Symbia T Series SPECT-CT (Single-Photon Emission Computed Tomography and Computed Tomography) System;
Code Information Part number 8717733, serial numbers 1019, 1020, 1021, 1023, 1041, 1042, 1043, 1052, 1054, 1067, 1072, 1073, 1077, 1090, 1091, 1103, 1106, 1109, 1121, 1125, 1127, 1128, 1135, 1138, 1140, 1147, 1150, 1153, 1157, 1158, 1162, 1163, 1168, 1169, 1170, 1171, 1173, 1174, 1175, 1178, 1180, 1181, 1184, 1187, 1191, 1193, 1194, 1196, 1198, 1199, 1202, 1204, 1208, and 1210; Part number 10275007, serial numbers 1001, 1006, 1007, 1009, 1011, 1012, 1014, 1015, 1018, 1023, 1026, 1029, 1030, 1032, 1034, 1035, 1038, 1039, 1040, 1041, 1043, 1044, 1053, 1057, 1058, 1059, 1060, 1061, 1064, 1065, 1069, and 1071 Part number 1075008, serial numbers 1002, 1003, 1009, 1010, 1011, 1017, 1018, 1019, 1020, 1023, 1024, 1031, 1035, 1038, 1041, 1047, 1055, 1056, 1057, 1058, 1063, 1065, 1066, 1069, 1071, and 1076; Part number 10275009, serial numbers 1008, 1013, 1015, 1017, 1019, 1020, 1022, 1024, 1026, 1027, 1028, 1029, 1030, 1032, 1034, 1039, 1040, 1044, 1046, 1047, 1050, 1051, 1054, 1055, and 1056; Part number 10275010, serial numbers 1001, 1002, 1003, 1004, 1006, 1007, 1008, 1010, 1011, 1012, and 1013
Recalling Firm/
Manufacturer
Siemens Medical Solutions USA, Inc.
2501 Barrington Rd
Hoffman Estates, Illinois 60195-2061
For Additional Information Contact Mr. Ron Nolte
847-304-7700
Manufacturer Reason
for Recall
Patient injury can occur when the patient is lying on the patient bed and the automatic collimator exchanger is undergoing a collimator change operation at the launch of an acquisition workflow. Detector motions required for this change can cause collision with the patient or pallet if it is in brain scan position, i.e. the patient or pallet is into the field of view.
FDA Determined
Cause 2
DESIGN: Software Design (Manufacturing Process)
Action Siemens sent Urgent Field Correction Recall letters dated 1/20/09 to all users of the Symbia S and Symbia T Systems. The accounts were informed of the potential injury to patients while lying on the patient bed and the automatic collimator exchanger is undergoing a collimator change operation at the launch of an acquisition workflow. The customers were advised to perform all necessary collimator changes before the patient is positioned on the patient bed, and to examine each of their workflows that include a Tomo Acquisition activity and make sure the Auto Collimator Change check box on the Camera Parameters Tab is not checked. They also were advised that a Siemens Customer Service Representative would contact them within 60 days to schedule a corrective software upgrade free of charge. Any questions were directed to contact Siemens Medical Solutions USA, Inc. at 1-800-767-2313 (USA) for assistance. The accounts were requested to complete the Mandatory Fax-Back Form acknowledging receipt and understanding of the letter.
Quantity in Commerce 148 units
Distribution Worldwide distribution, including USA, Australia, Austria, Canada, China, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Ireland, Italy, Japan, Korea, Kuwait, Netherlands, Norway, Poland, Portugal, Qatar, Saudi Arabia, South Africa, Spain, Sweden and Switzerland.
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 = KPS and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC.
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