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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 74192

33 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
April 22, 2016
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Siemens Medical Solutions USA Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

33 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 33

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.

Z-2005-2016
Recall number
Z-2005-2016
Initiated
April 22, 2016
Classification
Class II
Status
Terminated
Quantity
83 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code 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

Distribution pattern

Worldwide Distribution - US Nationwide

device · product 2 of 33

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.

Z-2006-2016
Recall number
Z-2006-2016
Initiated
April 22, 2016
Classification
Class II
Status
Terminated
Quantity
36 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code 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

Distribution pattern

Worldwide Distribution - US Nationwide

device · product 3 of 33

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.

Z-2007-2016
Recall number
Z-2007-2016
Initiated
April 22, 2016
Classification
Class II
Status
Terminated
Quantity
5 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

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

Distribution pattern

Worldwide Distribution - US Nationwide

device · product 4 of 33

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.

Z-2008-2016
Recall number
Z-2008-2016
Initiated
April 22, 2016
Classification
Class II
Status
Terminated
Quantity
48 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code 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

Distribution pattern

Worldwide Distribution - US Nationwide

device · product 5 of 33

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.

Z-2009-2016
Recall number
Z-2009-2016
Initiated
April 22, 2016
Classification
Class II
Status
Terminated
Quantity
46 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code 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

Distribution pattern

Worldwide Distribution - US Nationwide

device · product 6 of 33

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.

Z-2010-2016
Recall number
Z-2010-2016
Initiated
April 22, 2016
Classification
Class II
Status
Terminated
Quantity
1 unit

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Serial Number 1001

Distribution pattern

Worldwide Distribution - US Nationwide

device · product 7 of 33

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.

Z-2011-2016
Recall number
Z-2011-2016
Initiated
April 22, 2016
Classification
Class II
Status
Terminated
Quantity
1 unit

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Serial Number 45646

Distribution pattern

Worldwide Distribution - US Nationwide

device · product 8 of 33

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.

Z-2012-2016
Recall number
Z-2012-2016
Initiated
April 22, 2016
Classification
Class II
Status
Terminated
Quantity
102 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code 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

Distribution pattern

Worldwide Distribution - US Nationwide

device · product 9 of 33

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.

Z-2013-2016
Recall number
Z-2013-2016
Initiated
April 22, 2016
Classification
Class II
Status
Terminated
Quantity
15 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

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

Distribution pattern

Worldwide Distribution - US Nationwide

device · product 10 of 33

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.

Z-2014-2016
Recall number
Z-2014-2016
Initiated
April 22, 2016
Classification
Class II
Status
Terminated
Quantity
16 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

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

Distribution pattern

Worldwide Distribution - US Nationwide

device · product 11 of 33

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.

Z-2015-2016
Recall number
Z-2015-2016
Initiated
April 22, 2016
Classification
Class II
Status
Terminated
Quantity
49 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code 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

Distribution pattern

Worldwide Distribution - US Nationwide

device · product 12 of 33

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.

Z-2016-2016
Recall number
Z-2016-2016
Initiated
April 22, 2016
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code 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

Distribution pattern

Worldwide Distribution - US Nationwide

device · product 13 of 33

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.

Z-2017-2016
Recall number
Z-2017-2016
Initiated
April 22, 2016
Classification
Class II
Status
Terminated
Quantity
2 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Serial Numbers: 72418,72428

Distribution pattern

Worldwide Distribution - US Nationwide

device · product 14 of 33

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.

Z-2018-2016
Recall number
Z-2018-2016
Initiated
April 22, 2016
Classification
Class II
Status
Terminated
Quantity
4 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Serial Numbers: 1001,1003,1010,11012

Distribution pattern

Worldwide Distribution - US Nationwide

device · product 15 of 33

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.

Z-2019-2016
Recall number
Z-2019-2016
Initiated
April 22, 2016
Classification
Class II
Status
Terminated
Quantity
2 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Serial Numbers: 1007,1008

Distribution pattern

Worldwide Distribution - US Nationwide

device · product 16 of 33

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.

Z-2020-2016
Recall number
Z-2020-2016
Initiated
April 22, 2016
Classification
Class II
Status
Terminated
Quantity
9 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

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

Distribution pattern

Worldwide Distribution - US Nationwide

device · product 17 of 33

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.

Z-2021-2016
Recall number
Z-2021-2016
Initiated
April 22, 2016
Classification
Class II
Status
Terminated
Quantity
28 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code 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

Distribution pattern

Worldwide Distribution - US Nationwide

device · product 18 of 33

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.

Z-2022-2016
Recall number
Z-2022-2016
Initiated
April 22, 2016
Classification
Class II
Status
Terminated
Quantity
3 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Serial Numbers: 11001,11002,11003

Distribution pattern

Worldwide Distribution - US Nationwide

device · product 19 of 33

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.

Z-2023-2016
Recall number
Z-2023-2016
Initiated
April 22, 2016
Classification
Class II
Status
Terminated
Quantity
9 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

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

Distribution pattern

Worldwide Distribution - US Nationwide

device · product 20 of 33

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.

Z-2024-2016
Recall number
Z-2024-2016
Initiated
April 22, 2016
Classification
Class II
Status
Terminated
Quantity
12 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

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

Distribution pattern

Worldwide Distribution - US Nationwide

device · product 21 of 33

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.

Z-2025-2016
Recall number
Z-2025-2016
Initiated
April 22, 2016
Classification
Class II
Status
Terminated
Quantity
25 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code 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

Distribution pattern

Worldwide Distribution - US Nationwide

device · product 22 of 33

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.

Z-2026-2016
Recall number
Z-2026-2016
Initiated
April 22, 2016
Classification
Class II
Status
Terminated
Quantity
2 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Serial Numbers: 11001,11002

Distribution pattern

Worldwide Distribution - US Nationwide

device · product 23 of 33

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.

Z-2027-2016
Recall number
Z-2027-2016
Initiated
April 22, 2016
Classification
Class II
Status
Terminated
Quantity
13 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

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

Distribution pattern

Worldwide Distribution - US Nationwide

device · product 24 of 33

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.

Z-2028-2016
Recall number
Z-2028-2016
Initiated
April 22, 2016
Classification
Class II
Status
Terminated
Quantity
143 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code 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

Distribution pattern

Worldwide Distribution - US Nationwide

device · product 25 of 33

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.

Z-2029-2016
Recall number
Z-2029-2016
Initiated
April 22, 2016
Classification
Class II
Status
Terminated
Quantity
5 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

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

Distribution pattern

Worldwide Distribution - US Nationwide

device · product 26 of 33

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.

Z-2030-2016
Recall number
Z-2030-2016
Initiated
April 22, 2016
Classification
Class II
Status
Terminated
Quantity
47 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code 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

Distribution pattern

Worldwide Distribution - US Nationwide

device · product 27 of 33

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.

Z-2031-2016
Recall number
Z-2031-2016
Initiated
April 22, 2016
Classification
Class II
Status
Terminated
Quantity
100 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code 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

Distribution pattern

Worldwide Distribution - US Nationwide

device · product 28 of 33

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.

Z-2032-2016
Recall number
Z-2032-2016
Initiated
April 22, 2016
Classification
Class II
Status
Terminated
Quantity
51 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code 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

Distribution pattern

Worldwide Distribution - US Nationwide

device · product 29 of 33

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.

Z-2033-2016
Recall number
Z-2033-2016
Initiated
April 22, 2016
Classification
Class II
Status
Terminated
Quantity
127 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code 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

Distribution pattern

Worldwide Distribution - US Nationwide

device · product 30 of 33

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.

Z-2034-2016
Recall number
Z-2034-2016
Initiated
April 22, 2016
Classification
Class II
Status
Terminated
Quantity
22 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code 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

Distribution pattern

Worldwide Distribution - US Nationwide

device · product 31 of 33

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.

Z-2035-2016
Recall number
Z-2035-2016
Initiated
April 22, 2016
Classification
Class II
Status
Terminated
Quantity
4 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Serial Numbers: 1002,1001,11003,11004

Distribution pattern

Worldwide Distribution - US Nationwide

device · product 32 of 33

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.

Z-2036-2016
Recall number
Z-2036-2016
Initiated
April 22, 2016
Classification
Class II
Status
Terminated
Quantity
2 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Serial Numbers: 1001,1002

Distribution pattern

Worldwide Distribution - US Nationwide

device · product 33 of 33

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.

Z-2037-2016
Recall number
Z-2037-2016
Initiated
April 22, 2016
Classification
Class II
Status
Terminated
Quantity
63 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code 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

Distribution pattern

Worldwide Distribution - US Nationwide