Class 2 Device Recall Symbia S Series SPECT System

• Date Initiated by Firm: December 11, 2009
• Date Posted: December 29, 2009
• Recall Status: Terminated on August 27, 2012
• Recall Number: Z-0583-2010
• Recall Event ID: 53919
• 510(K)Number: K041166
• Product Classification: System, tomography, computed, emission - Product Code KPS
• Product: Symbia S Series SPECT System; Single-Photon Emission Computed Tomography; 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: 8717741, Serial Numbers: 1006, 1007, 1008, 1009, 1019, 1021, 1022, 1024, 1032, 1033, 1034, 1035, 1038, 1044, 1045, 1049, 1051, 1054, 1057, 1058, 1062, 1067, 1069, 1073, 1081, 1082, 1083, 1088, 1092, 1094, 1095, 1103, 1104, 1115, 1116, 1121, 1124, 1126, 1128, 1133, 1135, 1136, 1137, 1138, 1145, 1149, 1150, 1151, 1152, 1156, 1157, 1159, 1160, 1161, 1162, 1163, 1167, 1169, 1179, 1181, 1182, 1183, 1184, 1186, 1187, 1190, 1191, 1197, 1199, 1201, 1207, 1211, 1214, 1215, 1216, 1220, 1224, 1225, 1229, 1230, 1232, 1242, 1243, 1245, 1246, 1252, 1253, 1254, 1255, 1258, 1267, 1269, 1271, 1275, 1277, 1282, 1288, 1293, 1299, 1304, 1312, 1313, 1317, 1320, 1321, 1322, 1323, 1327, 1329, 1331, 1332, 1334, 1343, 1348, 1349, 1363, 1364, 1366, 1368, 1372, 1376, 1380, 1385, 1386, 1387, 1389, 1392, 1398, 1399, 1402, 1404, 1405, 1409, 1411 and 1412.
• Recalling Firm/ Manufacturer: Siemens Medical Solutions USA, Inc.; 2501 Barrington Rd; Hoffman Estates IL 60195-2061
• For Additional Information Contact: Mr. 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: 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: 135 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.
• Total Product Life Cycle: TPLC 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) Database: 510(K)s with Product Code = KPS