Z-2934-2020Class II

Symbia S-Series and Symbia T-Series -

Name: Z-2934-2020 Symbia S-Series and Symbia T-Series -
Creator: Siemens Medical Solutions USA, Inc.
Published: 2020-08-14
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2020-08-14 / Terminated / root cause: design

FDA source

Siemens Medical Solutions USA, Inc. began a recall of Symbia S-Series and Symbia T-Series - Product Usage: Intended use of the device SPECT: To detect or image the distribution of radionuclides in the body or... on 2020-08-14. FDA classified it as Class II and gives the reason as "This letter is to inform you of the possibility that your Symbia S or Symbia T system(s) may have unintended slow motion of the detectors in specific situations which could pose a potential risk". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2934-2020
Classification: Class II
Status: Terminated
Initiated: 2020-08-14
Posted: 2020-09-02
Terminated: 2023-05-01
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Symbia S-Series and Symbia T-Series - Product Usage: Intended use of the device SPECT: To detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588keV.
Product code: KPS System, Tomography, Computed, Emission
Reason for recall: This letter is to inform you of the possibility that your Symbia S or Symbia T system(s) may have unintended slow motion of the detectors in specific situations which could pose a potential risk.
Root cause tag: design
FDA root cause: Device Design
Action: On 8/14/20 the firm notified their customers via letter of the field action, with the following instructions: How can you help to avoid the potential risk of this issue? You may continue to use your system ensuring to follow all instructions in the Operator Manual. Do not leave the patient unattended at any time while the patient is positioned on the patient bed. Siemens Medical Solutions USA, Inc. 2501 N. Barrington Road Hoffman Estates, IL 60192 USA In the event of an Emergency-Stop, shutdown or power loss the patient should be manually retracted from the gantry using the patient bed pallet handle and release button. In the event of touchpad engagement, confirm there are no system errors reported on the PPM and refer to the instructions in the Operator Manual to address proper patient positioning before continuing. If unintended detector motion is observed, downward pressure from the detector is reported by the patient at any time or the PPM presents a system error (as shown in the picture below), then manually retract the patient from the gantry using the patient bed handle and release button, stop use of the system and contact your customer service representative. Errors or problems that result in patient re-scan or re-dose should be reported to your local Siemens Healthiness representative.
Quantity in commerce: 412 units
Distribution: US Nationwide distribution including in the states of Alabama, Alaska, Arizona, California, Colorado, District of Columbia, Florida, Georgia, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Missouri, Nebraska, New Jersey, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, West Virginia and Wisconsin.
Product codes and lots: Model:8717741, 8717733, 10275007, 10275008, 10275009, 10275010 Serial Numbers: 1054, 1075, 1124, 1019, 1235, 1230, 1002, 1019, 1105, 1135, 1217, 1158, 1026, 1037, 1081, 1128, 1165 1013, 1009, 1049, 1050, 1067, 1077, 1144, 1150, 1151, 1179, 1191, 1210, 1247, 1074, 1149, 1202, 1180, 1017, 1018, 1055, 1048, 1080, 1131, 1173, 1176, 1008, 1203, 1077, 1076, 1079, 1095, 1115, 1215, 1152, 1001, 1046, 1055, 1109, 1184, 1236, 1001, 1092, 1160, 1193, 1023, 1028, 1032, 1096, 1207, 1219, 1250, 1022, 1175, 1132, 1023, 1145, 1177, 1052, 1045, 1152, 1016, 1027, 1182, 1066, 1072, 1136, 1216, 1019, 1203, 1011, 1011, 1126, 1142, 1010, 1024, 1029, 1053, 1089, 1178, 1001, 1206, 1252, 1122, 1143, 1015, 1027, 1245, 1012, 1011, 1028, 1029, 1243, 1113, 1198, 1154, 1018, 1036, 1071, 1097, 1099, 1170, 1052, 1195, 1034, 1088, 1121, 1133, 1139, 1208, 1007, 1248, 1167, 1137, 1004, 1011, 1015, 1051, 1060, 1104, 1110, 1114, 1134, 1142, 1168, 1171, 1192, 1212, 1218, 1220, 1232, 1240, 1241, 1242, 1029, 1148, 1229, 1231, 1067, 1082, 1249, 1030, 1037, 1065, 1017, 1033, 1064, 1108, 1125, 1183, 1194, 1196, 1205, 1080, 1169, 1170, 1041, 1093, 1118, 1139, 1161, 1201, 1025, 1084, 1120, 1174, 1020, 1191, 1003, 1005, 1006, 1073, 1094, 1123, 1126, 1222, 1225, 1233, 1002, 1208, 1100, 1013, 1014, 1083, 1118, 1119, 1129, 1162, 1163, 1204, 1007, 1138, 1186, 1133, 1091, 1014, 1182, 1039, 1057, 1065, 1197, 1024.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2934-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2934-2020	Class II	Terminated	Voluntary: Firm initiated	2020-09-09	2020-09-02

Product code KPS

K200474Class IISymbia 6.7Siemens Medical Solutions USA, Inc. / cleared 2020-03-20

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)