FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc.: 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.
- Recall number
- Z-0583-2010
- Recalling firm
- Siemens Medical Solutions USA, Inc.
- 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.
- Status
- Terminated
- Initiated
- 2009-12-11
- Posted
- 2009-12-29
- Terminated
- 2012-08-27
- Reason
- 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
- 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
- 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.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- ["K041166"]
- PMA numbers
- not on file
- Product code
- KPS
- Firm FEI
- 1000514697
- Firm city
- Hoffman Estates
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28