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Z-0584-2010

Symbia T Series SPECT-CT (Single-Photon Emission Computed Tomography and Computed Tomography) System; Siemens...

Siemens Medical Solutions USA, Inc. / initiated 2009-12-11 / Terminated / root cause: manufacturing process
FDA source (opens on fda.gov)

Siemens Medical Solutions USA, Inc. began a recall of Symbia T Series SPECT-CT (Single-Photon Emission Computed Tomography and Computed Tomography) System; Siemens Medical Solutions USA, Inc., Hoffman Estates, IL... on . The reason FDA records is "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". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number
Z-0584-2010
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Siemens Medical Solutions USA, Inc.
Product
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.
Product code
JAK System, X-Ray, Tomography, Computed
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.
Root cause tag
manufacturing process
FDA root cause
Process control
Action
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).
Quantity in commerce
97 units
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.
Product codes and lots
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.