Siemens Medical Solutions USA, Inc.: Siemens Medical Solutions USA, Inc., Symbia S Series SPECT System; Single-Photon Emission Computed Tomography; Part number 8717741.

Recall number

Z-1648-2009

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.

Status

Terminated

Initiated

2009-03-11

Posted

2009-07-07

Terminated

2010-09-11

Reason

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

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

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.

Lot, serial or model codes

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

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

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

Copy