| Class 2 Device Recall SPECT/CT System | |
Date Initiated by Firm | August 14, 2020 |
Create Date | September 02, 2020 |
Recall Status1 |
Terminated 3 on May 01, 2023 |
Recall Number | Z-2934-2020 |
Recall Event ID |
86262 |
510(K)Number | K200474 |
Product Classification |
System, tomography, computed, emission - Product Code KPS
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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. |
Code Information |
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. |
Recalling Firm/ Manufacturer |
Siemens Medical Solutions USA, Inc. 2501 Barrington Rd Hoffman Estates IL 60192-2061
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For Additional Information Contact | Laura Meyer 847-304-7700 |
Manufacturer 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. |
FDA Determined Cause 2 | 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. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = KPS
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