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

Agency Publication Date: January 10, 2017

Affected Products

Product: 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

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

Product: 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

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

Product: 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 ang

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

Product: 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

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

Product: 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

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

Product: 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 ang

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

Product: 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 di

Serial Numbers: 1002

Product: 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

Serial Numbers: 1001

Product: 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

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

Product: 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 diffe

Serial Numbers: 11001

Product: 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 differe

Serial Numbers: 11001

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 76127

Status: Resolved

Manufacturer: Siemens Medical Solutions USA Inc.

Manufactured In: United States

Units Affected: 11 products (41 units; 34 units; 71 units; 88 units; 102 units; 18 units; 1 unit; 1 unit; 51 units; 1 unit; 1 unit)

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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.

Affected Products

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

Serial Numbers: 1002

Serial Numbers: 1001

Serial Numbers: 11001