Siemens Medical Solutions USA Inc.: Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.

Agency Publication Date: June 21, 2016

Affected Products

Product: Biograph mCT-X 4R, MATERIAL NUMBER 10248670 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.

Serial Numbers: 1002,1003,1001,1004,1005,1006,1008,1009,1010,1007,1011,11013,11014,11015,11016,11017,11018,11020,11012,11019,11021,11022,11023,11026,11025,11024,11027,11044,11029,11028,11030,11031,11032,11033,11034,11037,11036,11038,11040,11042,11039,11035,11045,11046,11041,11047,11048, 11049,11050,11051,11052,11054,11055,11056,11043,11058,11059,11057,11061,11060,11062,11063,11064,11065,11066,11067,11068,11069,11070,21071,21073,21072,21074,31075,31076,31077,31083,31079,31080,31081,31082,31078,40001091760

Product: Biograph 16 TruePoint TV, Material Number 10249556 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.

Serial Numbers: 72405,72408,72409,72411,72412,72413,72415,72416,72423,72430,72438,72439,72446,72447,72449,72451,72452,72454,72456,72458,72462,72463,72469,72473,72478,72482,72483,72488,72490,72500,72506,72507,72508,72510,72516,72536

Product: BIOGRAPH 40 - 3 Ring, Material Number 10097233 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.

Serial Numbers: 1001,1004,1009,1012,1014

Product: BIOGRAPH 40 TruePoint, Material Number 10097303 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.

Serial Numbers: 1003,1004,1005,1006,1009,1011,1012,1013,1014,1015,1016,1017,1018,1019,1020,1022,1023,1024,1028,1029,1030,1031,1032,1033,1034,1035,1036,1037,1039,1041,1042,1043,1044,1045,1046,1047,1049,1050,1051,1052,1053,1054,11055,11056,11059,11060,11061,11063

Product: BIOGRAPH 40 TruePoint w/TrueV, Material Number 10097304 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.

Serial Numbers: 1001,1002,1003,1004,1005,1006,1007,1008,1009,1010,1011,1012,1013,1014,1015,1016,1017,1018,1019,1021,1022,1023,1024,1025,1026,1027,1028,1029,1031,1033,1034,1035,1037,1038,1040,1042,1043,1044,1045,1046,1047,1048,1049,1050,1051,1053

Product: BIOGRAPH 40-3R to 64-3R Upgrade, Material Number 10246390 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.

Serial Number 1001

Product: Biograph 6 TP 3R to 4R Upgrade, Material Number 10246387 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.

Serial Number 45646

Product: BIOGRAPH 6 TruePoint, Material Number 10097289 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.

Serial Numbers: 1003,1004,1009,1013,1016,1028,1031,1032,1033,1036,1037,1038,1040,1042,1052,1059,1066,1070,1083,1095,44983,45511,45514,45519,45523,45530,45531,45535,45537,45538,45540,45542,45543,45550,45551,45567,45568,45569,45570,45571,45573,45575,45577,45578,45579,45581,45583,45588,45593,45595,45599,45602,45603,45604,45607,45609,45610,45611,45613,45614,45618,45619,45620,45621,45623,45624,45625,45627,45628,45629,45630,45631,45633,45635,45636,45637,45638,45639,45640,45642,45643,45644,45645,45648,45649,45650,45651,45652,45653,45654,45655,45657,45658,45659,45661,45662,45663,45664,45666,45701,45702,45703

Product: BIOGRAPH 64 - 3 Ring, Material Number 08727450 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.

Serial Numbers: 1001,1002,1003,1004,1007,1010,1012,1013,1014,1015,1016,1017,1018,1019,1022

Product: BIOGRAPH 64-3R TruePoint, MATERIAL NUMBER 10097301 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.

Serial Numbers: 1021,1024,1027,1029,1030,1031,1032,1033,1034,1037,11044,11045,11046,11047,11048,11049

Product: BIOGRAPH 64-4R TruePoint w/TrueV, MATERIAL NUMBER 10097302 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.

Serial Numbers: 1002,1003,1004,1005,1006,1007,1008,1011,1013,1014,1015,1016,1017,1019,1020,1021,1022,1023,1024,1025,1028,1029,1030,1031,1032,1033,1034,1036,1037,1038,1039,1041,1042,1043,1045,1046,1048,1049,1050,1051,1052,1054,1055,11057,11059,11060,11061,11063,58004

Product: BIOGRAPH 6-4R TruePoint w/TrueV, MATERIAL NUMBER 10097290 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.

Serial Numbers: 1001,1004,1015,1020,1024,1035,1042,44889,44977,45502,45509,45516,45518,45520,45522,45525,45527,45528,45532,45533,45539,45544,45547,45549,45554,45556,45560,45564,45574,45586,45587,45590,45600,45612,45615,45656,45660

Product: Biograph Sys 16-3R to 16-4R upgrade, MATERIAL NUMBER 10525581 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.

Serial Numbers: 72418,72428

Product: BIOGRAPH Sys 40-3R to 40-4R, MATERIAL NUMBER 10246388 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.

Serial Numbers: 1001,1003,1010,11012

Product: BIOGRAPH SYS 64-3R to 64-4R, MATERIAL NUMBER 10246389 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.

Serial Numbers: 1007,1008

Product: BIOGRAPH mCT Flow 20-3R, MATERIAL NUMBER 10528956 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.

Serial Numbers: 11001,11002,11003,11004,11005,11006,11007,11009,59001

Product: BIOGRAPH mCT Flow 20-4R, MATERIAL NUMBER 10528958 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.

Serial Numbers: 11001,11002,11003,11004,11005,11007,11006,11008,11009,11010,11011,11012,11013,11014,11015,11016,11017,11018,11019,11020,11021,11023,11022,11024,11026,11027,11025,11030

Product: BIOGRAPH mCT Flow 40-3R, MATERIAL NUMBER 10529158 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.

Serial Numbers: 11001,11002,11003

Product: BIOGRAPH mCT Flow 40-4R, MATERIAL NUMBER 10529159 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.

Serial Numbers: 11004,11001,11002,11003,11005,11006,11007,11008,11009

Product: BIOGRAPH mCT Flow 64-3R, MATERIAL NUMBER 10529160 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.

Serial Numbers: 11001,11002,11003,11006,11004,11007,11008,11009,11005,11010,11011,11012

Product: BIOGRAPH mCT Flow 64-4R, MATERIAL NUMBER 10529161 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.

Serial Numbers: 11002,11003,11004,11001,11005,11006,11008,11009,11007,11010,11011,11012,11014,11015,11013,11017,11016,11021,11018,11019,11025,11023,11022,60001,11026

Product: BIOGRAPH mCT Flow Edge-3R, MATERIAL NUMBER 10528954 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.

Serial Numbers: 11001,11002

Product: BIOGRAPH mCT Flow Edge-4R, MATERIAL NUMBER 10528955 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.

Serial Numbers; 11001,11002,11003,11004,11005,11006,11007,11008,11009,11011,11010,11013,11012

Product: BIOGRAPH mCT S(20) - 3R, MATERIAL NUMBER 10507786 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.

Serial Numbers: 11001,11002,11005,11006,11007,11009,11012,11013,11014,11015,11003,11017,11019,11020,11010,11022,11008,11004,11024,11040,11026,11027,11028,11018,11023,11029,11021,11041,11032,11034,11035,11030,11036,11037,11038,11039,11025,11045,21084,11042,11046,11049,21063,11043,11050, 11031,11033,21052,21054,21053,21056,21057,21058,21059,21060,21061,21062,21065,21066,21067,11044,21068,11047,21071,21072,21073,21069,21075,21076,21077,21055,21078,21081,21080,21051,21082,21064,21070,21074,21086,21087,21079,21085,21083,21126,21090,21091,21092,21095,21093, 21094,21088,21098,21096,21100,21097,21101,21103,21104,21105,21106,21107,21110,21111,21109,21112,21115,21099,21136,21117,21118,21120,21122,21123,21102,21125,21116,21127,21128,21119,21114,21108,21131,21134,21135,21113,21137,21130,21138,21124,21121,21129,21142,21141,21144, 21149,21150,11011,11016,21089,21143,21145,21148

Product: BIOGRAPH mCT S(20)-4R, MATERIAL NUMBER 10534160 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.

Serial Numbers: 31001,31002,31003,31004,60001

Product: Biograph mCT-S(40) 3R, MATERIAL NUMBER 10248668 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.

Serial Numbers: 1002,1004,1006,1007,1005,1010,1013,1016,1017,11018,11019,11031,1012,11020,1014,11026,11022, 1015,11024,11025,11023,11027,11028,11030,11032,11038,11033,11034,11036,11039,11037,11040, 11041,11044,11042,21045,21048,31047,31049,11029,1008,1009,1011,11021,11033,11035,31046

Product: Biograph mCT-S(40) 4R, MATERIAL NUMBER 10248671 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.

Serial Numbers: 1024,1001,1002,1003,1005,1006,1007,1008,1009,1011,1012,1013,1004,1014,1017,1018,1019,1020,1022,1010,1023,11034,1016,1015,1025,11026,11029,11028,11030,11031,11035,11032,11033,11027,11036,11037,11039,11038,11040,11043,11044,11045,11046,11083,11047,11041,11042,11049,11051,11050,11053,11054,11055,11056,11057,11058,11059,11076,11060,11061,11062,11063,11064,11052,11065,11048,11074,11069,11067,11068,11070,11072,11075,11073,11066,11077,11078,11071,11080,11081,11082,11084,21085,21086,21087,21088,21089,21090,21091,31092,21093,31094,31095,31097,31096,31099,91001,31100,1021,31098

Product: Biograph mCT-S(64) 3R, MATERIAL NUMBER 10248669 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.

Serial Numbers: 1003,1004,1005,1006,1007,11009,11010,11011,11012,11013,11014,11023,11015,11016,11017,11018,11019,11020,11021,11022,11025,11028,11029,11027,31042,11024,11026,11033,11032,21034,31037,31040,21035,11031,11030,21036,31038,31039,31046,31041,31043,31045,31047,31048,31044,31049, 31050,31051,31054,1008,31053

Product: Biograph mCT-S(64) 4R, MATERIAL NUMBER 10248672 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.

Serial Numbers: 1013,11055,1005,1006,1004,1011,1003,1002,1008,1009,1010,11022,11028,1012,1016,1017,1019,11020,1007,11023,11024,11025,11026,11029,11030,11032,11033,11056,1018,11036,1014,11038,11039,11027,11049,11057,11040,11041,11042,11043,11031,11035,11044,11045,11034,11046,11047,11048,11037,11050,11051,11052,11053,11054,11058,11059,11060,11061,11062,11063,11064,11065,11067,11068,11069,11070,11071,11072,11074,11073,11075,11076,11066,11077,1001,11078,11079,11081,11083,11084,11082,11086,11087,11088,11080,11090,11091,11092,11094,11093,11096,21097,11095,21098,11089,21100,31110,21101,21102,21103,21099,21105,31106,11015,21104,31107,31108,31109,31111,31112,31113,31114,31124,31115,31117,31118,31119,31120,31121,90001,31122,31125,31126,1015,31116,31123,31127

Product: Biograph mCT-X 3R, MATERIAL NUMBER 10248673 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.

Serial Numbers: 1002,1003,1004,1005,1006,1007,11009,11010,11011,11012,11008,11013,11015,11019,11017,11018,11020,31021,31022,31023,11014,1001

Product: SYS IVK, Bio mCT-S(40) 3R->4R Upgrade, MATERIAL NUMBER 10250743 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.

Serial Numbers: 1002,1001,11003,11004

Product: SYS IVK, Bio mCT-X 3R->4R Upgrade, MATERIAL NUMBER 10250745 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.

Serial Numbers: 1001,1002

Product: Biograph 16 TruePoint, MATERIAL NUMBER 10249555 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.

Serial Numbers: 72402,72404,72407,72414,72419,72420,72421,72427,72429,72431,72433,72434,72435,72436,72437,72440,72441,72443,72444,72445,72448,72450,72453,72455,72457,72459,72460,72461,72464,72465,72466,72468,72471,72472,72475,72476,72477,72481,72486,72487,72489,72491,72492,72494,72495, 72496,72497,72499,72501,72502,72503,72504,72505,72512,72515,72521,72523,72526,72528,72530,72531,72535,72537

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 74192

Status: Resolved

Manufacturer: Siemens Medical Solutions USA Inc.

Manufactured In: United States

Units Affected: 32 products (83 units; 36 units; 5 units; 48 units; 46 units; 1 unit; 1 unit; 102 units; 15 units; 16 units; 49 units; 2 units; 4 units; 2 units; 9 units; 28 units; 3 units; 9 units; 12 units; 25 units; 2 units; 13 units; 143 units; 5 units; 47 units; 100 units; 51 units; 127 units; 22 units; 4 units; 2 units; 63 units)

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.