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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 76127

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

Open FDA event record

Event summary

Timeline bucket
December 13, 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

11 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 11

Biograph mCT S(40)-3R, Material Number 10248668 The Siemens Biograph mCT and Biograph mCT Flow 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. The CT component produces cross-sectional images of the body by computer reconstruction of X-Ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles. The PET subsystem images and measures the distribution of PET radiopharmaceuticals in humans for the purpose of determining various metabolic (molecular) and physiologic functions within the human body and utilizes the CT for fast attenuation correction maps for PET studies and precise anatomical reference for the fused PET and CT images. The system maintains independent functionality of the CT and PET devices, allowing for single modality CT and / or PET diagnostic imaging. These systems are intended to be utilized by appropriately trained health care professionals to aid in detecting, localizing, diagnosing, staging and restaging of lesions, tumors, disease and organ function for the evaluation of diseases and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The images produced by the system can also be used by the physician to aid in radiotherapy treatment planning and interventional radiology procedures.

Z-0992-2017
Recall number
Z-0992-2017
Initiated
December 13, 2016
Classification
Class II
Status
Terminated
Quantity
41 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Siemens Medical Solutions, Molecular Imaging has become aware, through our supplier that some laser cover windows may fall off.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Siemens Medical Solutions, Molecular Imaging has become aware, through our supplier that some laser cover windows may fall off.

Code information

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

Distribution pattern

Worldwide Distribution - US (nationwide) and Internationally to U.A.E., AT, AU, AZ, BR, CA, ,CH, CL, CN, CO, CZ, DE, DK, EG,FI, FR, GB, HK, HR, IL, IN, IR, IT, JP, KR, MX, NL, NO, NZ, PK, PL, QA, RO RU, SE, SG, SI, SK, TH, TR, AND TW.

device · product 2 of 11

Biograph mCT S(64)-3R, Material Number 10248669 The Siemens Biograph mCT and Biograph mCT Flow 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. The CT component produces cross-sectional images of the body by computer reconstruction of X-Ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles. The PET subsystem images and measures the distribution of PET radiopharmaceuticals in humans for the purpose of determining various metabolic (molecular) and physiologic functions within the human body and utilizes the CT for fast attenuation correction maps for PET studies and precise anatomical reference for the fused PET and CT images. The system maintains independent functionality of the CT and PET devices, allowing for single modality CT and / or PET diagnostic imaging. These systems are intended to be utilized by appropriately trained health care professionals to aid in detecting, localizing, diagnosing, staging and restaging of lesions, tumors, disease and organ function for the evaluation of diseases and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The images produced by the system can also be used by the physician to aid in radiotherapy treatment planning and interventional radiology procedures.

Z-0993-2017
Recall number
Z-0993-2017
Initiated
December 13, 2016
Classification
Class II
Status
Terminated
Quantity
34 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Siemens Medical Solutions, Molecular Imaging has become aware, through our supplier that some laser cover windows may fall off.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Siemens Medical Solutions, Molecular Imaging has become aware, through our supplier that some laser cover windows may fall off.

Code information

Serial Numbers: 1006, 11025, 11015, 11021, 11012, 11016, 11019, 1003, 1004, 11010, 11014, 11032, 1005, 11027, 11017, 11022, 11033, 11020, 11011, 21036, 11018, 11009, 11013, 11023, 11024, 11026, 11028, 11029, 11030, 11031, 21034, 31055

Distribution pattern

Worldwide Distribution - US (nationwide) and Internationally to U.A.E., AT, AU, AZ, BR, CA, ,CH, CL, CN, CO, CZ, DE, DK, EG,FI, FR, GB, HK, HR, IL, IN, IR, IT, JP, KR, MX, NL, NO, NZ, PK, PL, QA, RO RU, SE, SG, SI, SK, TH, TR, AND TW.

device · product 3 of 11

Biograph mCT X-4R, Material Number 10248670 The Siemens Biograph mCT and Biograph mCT Flow 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. The CT component produces cross-sectional images of the body by computer reconstruction of X-Ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles. The PET subsystem images and measures the distribution of PET radiopharmaceuticals in humans for the purpose of determining various metabolic (molecular) and physiologic functions within the human body and utilizes the CT for fast attenuation correction maps for PET studies and precise anatomical reference for the fused PET and CT images. The system maintains independent functionality of the CT and PET devices, allowing for single modality CT and / or PET diagnostic imaging. These systems are intended to be utilized by appropriately trained health care professionals to aid in detecting, localizing, diagnosing, staging and restaging of lesions, tumors, disease and organ function for the evaluation of diseases and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The images produced by the system can also be used by the physician to aid in radiotherapy treatment planning and interventional radiology procedures.

Z-0994-2017
Recall number
Z-0994-2017
Initiated
December 13, 2016
Classification
Class II
Status
Terminated
Quantity
71 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Siemens Medical Solutions, Molecular Imaging has become aware, through our supplier that some laser cover windows may fall off.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Siemens Medical Solutions, Molecular Imaging has become aware, through our supplier that some laser cover windows may fall off.

Code information

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

Distribution pattern

Worldwide Distribution - US (nationwide) and Internationally to U.A.E., AT, AU, AZ, BR, CA, ,CH, CL, CN, CO, CZ, DE, DK, EG,FI, FR, GB, HK, HR, IL, IN, IR, IT, JP, KR, MX, NL, NO, NZ, PK, PL, QA, RO RU, SE, SG, SI, SK, TH, TR, AND TW.

device · product 4 of 11

Biograph mCT S(40)-4R, Material Number 10248671 The Siemens Biograph mCT and Biograph mCT Flow 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. The CT component produces cross-sectional images of the body by computer reconstruction of X-Ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles. The PET subsystem images and measures the distribution of PET radiopharmaceuticals in humans for the purpose of determining various metabolic (molecular) and physiologic functions within the human body and utilizes the CT for fast attenuation correction maps for PET studies and precise anatomical reference for the fused PET and CT images. The system maintains independent functionality of the CT and PET devices, allowing for single modality CT and / or PET diagnostic imaging. These systems are intended to be utilized by appropriately trained health care professionals to aid in detecting, localizing, diagnosing, staging and restaging of lesions, tumors, disease and organ function for the evaluation of diseases and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The images produced by the system can also be used by the physician to aid in radiotherapy treatment planning and interventional radiology procedures.

Z-0995-2017
Recall number
Z-0995-2017
Initiated
December 13, 2016
Classification
Class II
Status
Terminated
Quantity
88 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Siemens Medical Solutions, Molecular Imaging has become aware, through our supplier that some laser cover windows may fall off.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Siemens Medical Solutions, Molecular Imaging has become aware, through our supplier that some laser cover windows may fall off.

Code information

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

Distribution pattern

Worldwide Distribution - US (nationwide) and Internationally to U.A.E., AT, AU, AZ, BR, CA, ,CH, CL, CN, CO, CZ, DE, DK, EG,FI, FR, GB, HK, HR, IL, IN, IR, IT, JP, KR, MX, NL, NO, NZ, PK, PL, QA, RO RU, SE, SG, SI, SK, TH, TR, AND TW.

device · product 5 of 11

Biograph mCT S(64)-4R, Material Number 10248672 The Siemens Biograph mCT and Biograph mCT Flow 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. The CT component produces cross-sectional images of the body by computer reconstruction of X-Ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles. The PET subsystem images and measures the distribution of PET radiopharmaceuticals in humans for the purpose of determining various metabolic (molecular) and physiologic functions within the human body and utilizes the CT for fast attenuation correction maps for PET studies and precise anatomical reference for the fused PET and CT images. The system maintains independent functionality of the CT and PET devices, allowing for single modality CT and / or PET diagnostic imaging. These systems are intended to be utilized by appropriately trained health care professionals to aid in detecting, localizing, diagnosing, staging and restaging of lesions, tumors, disease and organ function for the evaluation of diseases and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The images produced by the system can also be used by the physician to aid in radiotherapy treatment planning and interventional radiology procedures.

Z-0996-2017
Recall number
Z-0996-2017
Initiated
December 13, 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, through our supplier that some laser cover windows may fall off.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Siemens Medical Solutions, Molecular Imaging has become aware, through our supplier that some laser cover windows may fall off.

Code information

Serial Numbers: 1004, 11046, 11064, 11036, 11030, 11093, 11033, 11032, 11041, 11042, 11043, 11044, 11047, 11053, 11069, 11071, 11078, 11079, 11084, 11082, 11091, 11092, 21098, 21101, 21102, 21105, 21104, 1016, 11024, 11026, 11029, 11054, 11058, 11077, 11086, 11095, 11052, 11068, 11096, 11020, 11067, 11087, 11015, 1006, 1019, 11073, 11075, 11083, 21097, 11088, 21103, 1010, 11039, 11040, 11061, 11062, 11063, 11076, 11081, 21100, 11025, 11051, 11065, 11070, 11072, 11050, 11023, 1005, 11074, 11094, 1012, 11059, 11045, 1002, 1003, 1007, 1011, 1014, 1013, 1018, 11022, 11021, 11027, 11028, 11031, 11034, 11035, 11037, 11048, 11049, 11055, 11056, 11057, 11060, 11066, 11080, 11089, 11090, 21099, 1001, 1001

Distribution pattern

Worldwide Distribution - US (nationwide) and Internationally to U.A.E., AT, AU, AZ, BR, CA, ,CH, CL, CN, CO, CZ, DE, DK, EG,FI, FR, GB, HK, HR, IL, IN, IR, IT, JP, KR, MX, NL, NO, NZ, PK, PL, QA, RO RU, SE, SG, SI, SK, TH, TR, AND TW.

device · product 6 of 11

Biograph mCT X-3R, Material Number 10248673 The Siemens Biograph mCT and Biograph mCT Flow 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. The CT component produces cross-sectional images of the body by computer reconstruction of X-Ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles. The PET subsystem images and measures the distribution of PET radiopharmaceuticals in humans for the purpose of determining various metabolic (molecular) and physiologic functions within the human body and utilizes the CT for fast attenuation correction maps for PET studies and precise anatomical reference for the fused PET and CT images. The system maintains independent functionality of the CT and PET devices, allowing for single modality CT and / or PET diagnostic imaging. These systems are intended to be utilized by appropriately trained health care professionals to aid in detecting, localizing, diagnosing, staging and restaging of lesions, tumors, disease and organ function for the evaluation of diseases and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The images produced by the system can also be used by the physician to aid in radiotherapy treatment planning and interventional radiology procedures.

Z-0997-2017
Recall number
Z-0997-2017
Initiated
December 13, 2016
Classification
Class II
Status
Terminated
Quantity
18 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Siemens Medical Solutions, Molecular Imaging has become aware, through our supplier that some laser cover windows may fall off.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Siemens Medical Solutions, Molecular Imaging has become aware, through our supplier that some laser cover windows may fall off.

Code information

Serial Numbers: 11010, 11013, 11011, 11009, 1006, 1002, 1007, 11012, 11015, 11017, 11016, 1003, 1004, 1005, 11020, 11008, 11019

Distribution pattern

Worldwide Distribution - US (nationwide) and Internationally to U.A.E., AT, AU, AZ, BR, CA, ,CH, CL, CN, CO, CZ, DE, DK, EG,FI, FR, GB, HK, HR, IL, IN, IR, IT, JP, KR, MX, NL, NO, NZ, PK, PL, QA, RO RU, SE, SG, SI, SK, TH, TR, AND TW.

device · product 7 of 11

Bio mCT-S(40) 3R->4R Upgrade, Material Number 10250743 The Siemens Biograph mCT and Biograph mCT Flow 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. The CT component produces cross-sectional images of the body by computer reconstruction of X-Ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles. The PET subsystem images and measures the distribution of PET radiopharmaceuticals in humans for the purpose of determining various metabolic (molecular) and physiologic functions within the human body and utilizes the CT for fast attenuation correction maps for PET studies and precise anatomical reference for the fused PET and CT images. The system maintains independent functionality of the CT and PET devices, allowing for single modality CT and / or PET diagnostic imaging. These systems are intended to be utilized by appropriately trained health care professionals to aid in detecting, localizing, diagnosing, staging and restaging of lesions, tumors, disease and organ function for the evaluation of diseases and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The images produced by the system can also be used by the physician to aid in radiotherapy treatment planning and interventional radiology procedures.

Z-0998-2017
Recall number
Z-0998-2017
Initiated
December 13, 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, through our supplier that some laser cover windows may fall off.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Siemens Medical Solutions, Molecular Imaging has become aware, through our supplier that some laser cover windows may fall off.

Code information

Serial Numbers: 1002

Distribution pattern

Worldwide Distribution - US (nationwide) and Internationally to U.A.E., AT, AU, AZ, BR, CA, ,CH, CL, CN, CO, CZ, DE, DK, EG,FI, FR, GB, HK, HR, IL, IN, IR, IT, JP, KR, MX, NL, NO, NZ, PK, PL, QA, RO RU, SE, SG, SI, SK, TH, TR, AND TW.

device · product 8 of 11

Biograph mCT-X w/TrueV Upgrade, Material Number 10250745 The Siemens Biograph mCT and Biograph mCT Flow 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. The CT component produces cross-sectional images of the body by computer reconstruction of X-Ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles. The PET subsystem images and measures the distribution of PET radiopharmaceuticals in humans for the purpose of determining various metabolic (molecular) and physiologic functions within the human body and utilizes the CT for fast attenuation correction maps for PET studies and precise anatomical reference for the fused PET and CT images. The system maintains independent functionality of the CT and PET devices, allowing for single modality CT and / or PET diagnostic imaging. These systems are intended to be utilized by appropriately trained health care professionals to aid in detecting, localizing, diagnosing, staging and restaging of lesions, tumors, disease and organ function for the evaluation of diseases and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The images produced by the system can also be used by the physician to aid in radiotherapy treatment planning and interventional radiology procedures.

Z-0999-2017
Recall number
Z-0999-2017
Initiated
December 13, 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, through our supplier that some laser cover windows may fall off.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Siemens Medical Solutions, Molecular Imaging has become aware, through our supplier that some laser cover windows may fall off.

Code information

Serial Numbers: 1001

Distribution pattern

Worldwide Distribution - US (nationwide) and Internationally to U.A.E., AT, AU, AZ, BR, CA, ,CH, CL, CN, CO, CZ, DE, DK, EG,FI, FR, GB, HK, HR, IL, IN, IR, IT, JP, KR, MX, NL, NO, NZ, PK, PL, QA, RO RU, SE, SG, SI, SK, TH, TR, AND TW.

device · product 9 of 11

BIOGRAPH mCT 20 Excel, Material Number 10507786 The Siemens Biograph mCT and Biograph mCT Flow 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. The CT component produces cross-sectional images of the body by computer reconstruction of X-Ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles. The PET subsystem images and measures the distribution of PET radiopharmaceuticals in humans for the purpose of determining various metabolic (molecular) and physiologic functions within the human body and utilizes the CT for fast attenuation correction maps for PET studies and precise anatomical reference for the fused PET and CT images. The system maintains independent functionality of the CT and PET devices, allowing for single modality CT and / or PET diagnostic imaging. These systems are intended to be utilized by appropriately trained health care professionals to aid in detecting, localizing, diagnosing, staging and restaging of lesions, tumors, disease and organ function for the evaluation of diseases and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The images produced by the system can also be used by the physician to aid in radiotherapy treatment planning and interventional radiology procedures.

Z-1000-2017
Recall number
Z-1000-2017
Initiated
December 13, 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, through our supplier that some laser cover windows may fall off.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Siemens Medical Solutions, Molecular Imaging has become aware, through our supplier that some laser cover windows may fall off.

Code information

Serial Numbers: 11013, 11001, 11022, 11026, 11032, 11007, 11012, 11038, 11002, 11006, 11014, 11015, 11019, 11020, 11035, 11037, 11046, 11034, 11024, 11036, 11049, 11050, 11009, 11027, 11028, 11003, 11004, 11008, 11010, 11017, 11018, 11021, 11023, 11025, 11029, 11030, 11031, 11033, 11039, 11040, 11041, 11042, 11043, 11044, 11045, 11047, 21051, 21119

Distribution pattern

Worldwide Distribution - US (nationwide) and Internationally to U.A.E., AT, AU, AZ, BR, CA, ,CH, CL, CN, CO, CZ, DE, DK, EG,FI, FR, GB, HK, HR, IL, IN, IR, IT, JP, KR, MX, NL, NO, NZ, PK, PL, QA, RO RU, SE, SG, SI, SK, TH, TR, AND TW.

device · product 10 of 11

Biograph mCT Flow Edge-4R, Material Number 10528955 The Siemens Biograph mCT and Biograph mCT Flow 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. The CT component produces cross-sectional images of the body by computer reconstruction of X-Ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles. The PET subsystem images and measures the distribution of PET radiopharmaceuticals in humans for the purpose of determining various metabolic (molecular) and physiologic functions within the human body and utilizes the CT for fast attenuation correction maps for PET studies and precise anatomical reference for the fused PET and CT images. The system maintains independent functionality of the CT and PET devices, allowing for single modality CT and / or PET diagnostic imaging. These systems are intended to be utilized by appropriately trained health care professionals to aid in detecting, localizing, diagnosing, staging and restaging of lesions, tumors, disease and organ function for the evaluation of diseases and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The images produced by the system can also be used by the physician to aid in radiotherapy treatment planning and interventional radiology procedures.

Z-1001-2017
Recall number
Z-1001-2017
Initiated
December 13, 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, through our supplier that some laser cover windows may fall off.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Siemens Medical Solutions, Molecular Imaging has become aware, through our supplier that some laser cover windows may fall off.

Code information

Serial Numbers: 11001

Distribution pattern

Worldwide Distribution - US (nationwide) and Internationally to U.A.E., AT, AU, AZ, BR, CA, ,CH, CL, CN, CO, CZ, DE, DK, EG,FI, FR, GB, HK, HR, IL, IN, IR, IT, JP, KR, MX, NL, NO, NZ, PK, PL, QA, RO RU, SE, SG, SI, SK, TH, TR, AND TW.

device · product 11 of 11

Biograph mCT Flow 40-4R, Material Number 10529159 The Siemens Biograph mCT and Biograph mCT Flow 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. The CT component produces cross-sectional images of the body by computer reconstruction of X-Ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles. The PET subsystem images and measures the distribution of PET radiopharmaceuticals in humans for the purpose of determining various metabolic (molecular) and physiologic functions within the human body and utilizes the CT for fast attenuation correction maps for PET studies and precise anatomical reference for the fused PET and CT images. The system maintains independent functionality of the CT and PET devices, allowing for single modality CT and / or PET diagnostic imaging. These systems are intended to be utilized by appropriately trained health care professionals to aid in detecting, localizing, diagnosing, staging and restaging of lesions, tumors, disease and organ function for the evaluation of diseases and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The images produced by the system can also be used by the physician to aid in radiotherapy treatment planning and interventional radiology procedures.

Z-1002-2017
Recall number
Z-1002-2017
Initiated
December 13, 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, through our supplier that some laser cover windows may fall off.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Siemens Medical Solutions, Molecular Imaging has become aware, through our supplier that some laser cover windows may fall off.

Code information

Serial Numbers: 11001

Distribution pattern

Worldwide Distribution - US (nationwide) and Internationally to U.A.E., AT, AU, AZ, BR, CA, ,CH, CL, CN, CO, CZ, DE, DK, EG,FI, FR, GB, HK, HR, IL, IN, IR, IT, JP, KR, MX, NL, NO, NZ, PK, PL, QA, RO RU, SE, SG, SI, SK, TH, TR, AND TW.