—#80495

Product

Siemens Medical Solutions USA, Inc., Symbia T Series SPECT-CT (Single-Photon Emission Computed Tomography and Computed Tomography) System;

FDA product code: KPS — System, Tomography, Computed, Emission
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K041166
Affected lot / code info: 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

Why it was recalled

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.

Root cause (FDA determination)

Software design

Action the firm took

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.

Recalling firm

Firm: Siemens Medical Solutions USA, Inc.
Address: 2501 Barrington Rd, Hoffman Estates, Illinois 60195-2061

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2009-03-11
Posted by FDA: 2009-07-07
Terminated: 2010-09-11
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #80495. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.