—#86867

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.

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

Why it was recalled

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 (FDA determination)

Process control

Action the firm took

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).

Recalling firm

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

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2009-12-11
Posted by FDA: 2009-12-29
Terminated: 2012-08-27
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #86867. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.