Z-1648-2009

Siemens Medical Solutions USA, Inc., Symbia S Series SPECT System; Single-Photon Emission Computed...

Name: Z-1648-2009 Siemens Medical Solutions USA, Inc., Symbia S Series SPECT System; Single-Photon Emission Computed...
Creator: Siemens Medical Solutions USA, Inc.
Published: 2009-03-11
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2009-03-11 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc. began a recall of Siemens Medical Solutions USA, Inc., Symbia S Series SPECT System; Single-Photon Emission Computed Tomography; Part number 8717741 on 2009-03-11. The reason FDA records is "Patient injury can occur when the patient is lying on the patient bed and the automatic collimator exchanger is undergoing a collimator change operation at the launch of an acquisition workflow. Detector motions...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1648-2009
Status: Terminated
Initiated: 2009-03-11
Posted: 2009-07-07
Terminated: 2010-09-11
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Siemens Medical Solutions USA, Inc., Symbia S Series SPECT System; Single-Photon Emission Computed Tomography; Part number 8717741.
Product code: KPS System, Tomography, Computed, Emission
Reason for recall: Patient injury can occur when the patient is lying on the patient bed and the automatic collimator exchanger is undergoing a collimator change operation at the launch of an acquisition workflow. Detector motions required for this change can cause collision with the patient or pallet if it is in brain scan position, i.e. the patient or pallet is into the field of view.
Root cause tag: software
FDA root cause: Software design
Action: Siemens sent Urgent Field Correction Recall letters dated 1/20/09 to all users of the Symbia S and Symbia T Systems. The accounts were informed of the potential injury to patients while lying on the patient bed and the automatic collimator exchanger is undergoing a collimator change operation at the launch of an acquisition workflow. The customers were advised to perform all necessary collimator changes before the patient is positioned on the patient bed, and to examine each of their workflows that include a Tomo Acquisition activity and make sure the Auto Collimator Change check box on the Camera Parameters Tab is not checked. They also were advised that a Siemens Customer Service Representative would contact them within 60 days to schedule a corrective software upgrade free of charge. Any questions were directed to contact Siemens Medical Solutions USA, Inc. at 1-800-767-2313 (USA) for assistance. The accounts were requested to complete the Mandatory Fax-Back Form acknowledging receipt and understanding of the letter.
Quantity in commerce: 152 units
Distribution: Worldwide distribution, including USA, Australia, Austria, Canada, China, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Ireland, Italy, Japan, Korea, Kuwait, Netherlands, Norway, Poland, Portugal, Qatar, Saudi Arabia, South Africa, Spain, Sweden and Switzerland.
Product codes and lots: Part number 8717741, serial numbers 1001, 1002, 1003, 1005, 1006, 1014, 1052, 1066, 1070, 1073, 1074, 1081, 1085, 1108, 1109, 1110, 1112, 1113, 1117, 1118, 1119, 1120, 1123, 1124, 1126, 1128, 1129, 1131, 1132, 1137, 1138, 1142, 1144, 1148, 1159, 1161, 1162, 1163, 1167, 1171, 1172, 1173, 1174, 1176, 1177, 1179, 1180, 1183, 1186, 1187, 1189, 1192, 1196, 1197, 1198, 1200, 1201, 1203, 1204, 1205, 1206, 1207, 1211, 1212, 1214, 1215, 1216, 1217, 1218, 1223, 1224, 1225, 1227, 1229, 1230, 1231, 1236, 1239, 1240, 1241, 1242, 1243, 1244, 1245, 1246, 1248, 1249, 1252, 1253, 1254, 1257, 1258, 1259, 1262, 1263, 1264, 1266, 1267, 1268, 1270, 1271, 1272, 1274, 1276, 1281, 1282, 1285, 1287, 1288, 1291, 1292, 1293, 1295, 1296, 1298, 1299, 1300, 1301, 1302, 1303, 1304, 1305, 1306, 1308, 1309, 1310, 1311, 1312, 1313, 1314, 1316, 1318, 1319, 1322, 1323, 1327, 1328, 1329, 1332, 1334, 1336, 1337, 1340, 1341, 1343, 1346, 1347, 1348, 1349, 1350, 1351, and 1352

Product code KPS

K041166Class IISiemens Enhanced Imaging SystemSiemens Medical Solutions USA, Inc. / cleared 2004-05-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)