Symbia 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.
- Recall Initiated
- December 11, 2009
- Posted
- December 29, 2009
- Terminated
- August 27, 2012
- Recall Number
- Z-0584-2010
- Quantity
- 97 units
- Firm Location
- Hoffman Estates, IL
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.
Distribution
Worldwide 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.
Lot / Code Info
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.
Root Cause
Process control
Action Taken
Siemens 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).