Z-1086-2015Class II

The Siemens Symbia S series is intended to aid in detecting, localizing, diagnosing, staging and restaging of...

Name: Z-1086-2015 The Siemens Symbia S series is intended to aid in detecting, localizing, diagnosing, staging and restaging of...
Creator: Siemens Medical Solutions USA, Inc.
Published: 2012-10-23
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2012-10-23 / Terminated / root cause: design

FDA source

Siemens Medical Solutions USA, Inc. began a recall of The Siemens Symbia S series is intended to aid in detecting, localizing, diagnosing, staging and restaging of lesions, tumors, disease and organ function for... on 2012-10-23. FDA classified it as Class II and gives the reason as "There is a potential for the linear bearing car to fail allowing the ball bearings to fall out". 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-1086-2015
Classification: Class II
Status: Terminated
Initiated: 2012-10-23
Posted: 2015-02-10
Terminated: 2016-12-23
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: The Siemens Symbia S series is intended to aid in detecting, localizing, diagnosing, staging and restaging of lesions, tumors, disease and organ function for the evaluation of diseases and disorders. The images produced by the system can also be used by the physician to aid in radiotherapy treatment planning and interventional radiology procedures.
Product code: KPS System, Tomography, Computed, Emission
Reason for recall: There is a potential for the linear bearing car to fail allowing the ball bearings to fall out.
Root cause tag: design
FDA root cause: Component design/selection
Action: Consignees were not notified of this issue.
Quantity in commerce: 719 systems (global)
Distribution: Worldwide Distribution-US (nationwide) including DC and Puerto Rico and the states of AK, AL, AR, AZ, CA, CO, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, TN, TX, UT, VA, WA, WI, WV, and WY), and the countries of AUSTRALIA , AUSTRIA, BANGLADESH , BELGIUM , BRAZIL , BULGARIA , CANADA , CHILE , CHINA , COLOMBIA , CROATIA , CZECH REPUBLIC , DENMARK , ECUADOR , EGYPT , FINLAND , FRANCE , GERMANY , GREECE , HONG KONG , HUNGARY , INDIA , INDONESIA , IRAN , IRELAND , ISRAEL , ITALY , JAPAN , KUWAIT , LATVIA , LITHUANIA , MEXICO , MOROCCO , NETHERLANDS , NEW ZEALAND , NORWAY , PERU , PHILIPPINES , POLAND , PORTUGAL , QATAR , ROMANIA , RUSSIA , SAUDI ARABIA , SINGAPORE , SLOVAKIA , SOUTH AFRICA , SPAIN , SWEDEN , SWITZERLAND , TAIWAIN , THAILAND , TUNISIA , TURKEY , UNITED ARAB EMIRATES, UNITED KINGDOM , and VENEZUELA.
Product codes and lots: 1) Symbia S; Materal Number: 8717741; Serial Numbers: 1001 , 1002 , 1003 , 1005 , 1006 , 1007 , 1008 , 1009 , 1010 , 1011 , 1012 , 1013 , 1014 , 1015 , 1016 , 1017 , 1018 , 1019 , 1020 , 1021 , 1022 , 1023 , 1024 , 1025 , 1027 , 1028 , 1029 , 1030 , 1031 , 1032 , 1033 , 1034 , 1035 , 1036 , 1037 , 1038 , 1039 , 1040 , 1041 , 1042 , 1043 , 1044 , 1045 , 1046 , 1047 , 1048 , 1049 , 1050 , 1051 , 1052 , 1053 , 1054 , 1055 , 1056 , 1057 , 1058 , 1059 , 1060 , 1061 , 1062 , 1063 , 1064 , 1065 , 1066 , 1067 , 1068 , 1069 , 1070 , 1071 , 1072 , 1073 , 1074 , 1075 , 1076 , 1077 , 1078 , 1079 , 1080 , 1081 , 1082 , 1083 , 1084 , 1085 , 1086 , 1087 , 1088 , 1089 , 1090 , 1091 , 1092 , 1093 , 1094 , 1095 , 1096 , 1097 , 1098 , 1099 , 1100 , 1101 , 1102 , 1103 , 1104 , 1105 , 1106 , 1107 , 1108 , 1109 , 1110 , 1111 , 1112 , 1113 , 1114 , 1115 , 1116 , 1117 , 1118 , 1119 , 1120 , 1121 , 1122 , 1123 , 1124 , 1125 , 1126 , 1127 , 1128 , 1129 , 1130 , 1131 , 1132 , 1133 , 1134 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, 1712 , 1713 , 1714 , 1715 , 1716 , 1717 , 1718 , 1719 , 1720 , 1721 , 1722 , 1723 , 1724 , 1725 , 701158475

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1086-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1086-2015	Class II	Terminated	Voluntary: Firm initiated	2015-02-18	2015-02-10
Z-1087-2015	Class II	Terminated	Voluntary: Firm initiated	2015-02-18	2015-02-10

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)