Siemens Medical Solutions USA Inc.: The mobile-specific instructions was not shipped to a limited population of Biograph Mobile systems.

Agency Publication Date: February 28, 2017

Affected Products

Product: Biograph 6 TruePoint, Material Number 10097289 The Biograph Mobile PET/CTs are intended to be utilized by appropriately trained health care professionals to: ¿ Image and measure the distribution of injected positron emitting radiopharmaceuticals in humans for the purpose of determining various metabolic (molecular) and physiologic functions within the human body; and ¿ Produce cross-sectional images of the body by computer reconstruction of XRay transmission data from either the same axial

1010, 1024, 1038, 44976, 45509, 45530, 45573, 45583, 45601, 45604, 45619, 45621, 45627, 45639, 45640, 45646, 45655, 45658

Product: Biograph 6 TruePoint, Material Number 10097290 The Biograph Mobile PET/CTs are intended to be utilized by appropriately trained health care professionals to: ¿ Image and measure the distribution of injected positron emitting radiopharmaceuticals in humans for the purpose of determining various metabolic (molecular) and physiologic functions within the human body; and ¿ Produce cross-sectional images of the body by computer reconstruction of XRay transmission data from either the same axial

1010, 1015, 1034, 1044, 45503, 45537

Product: Biograph 16 TruePoint - 3R, Material Number 10249555 The Biograph Mobile PET/CTs are intended to be utilized by appropriately trained health care professionals to: ¿ Image and measure the distribution of injected positron emitting radiopharmaceuticals in humans for the purpose of determining various metabolic (molecular) and physiologic functions within the human body; and ¿ Produce cross-sectional images of the body by computer reconstruction of XRay transmission data from either the same

72444, 72470, 72476, 72480, 72487, 72494, 72515, 72526, 72545

Product: Biograph 16 TruePoint TrueV - 4R, Material Number 10249556 The Biograph Mobile PET/CTs are intended to be utilized by appropriately trained health care professionals to: ¿ Image and measure the distribution of injected positron emitting radiopharmaceuticals in humans for the purpose of determining various metabolic (molecular) and physiologic functions within the human body; and ¿ Produce cross-sectional images of the body by computer reconstruction of XRay transmission data from either the

72484, 72490, 72516, 72536

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 76228

Status: Resolved

Manufacturer: Siemens Medical Solutions USA Inc.

Manufactured In: United States

Units Affected: 4 products (18 units; 6 units; 9 units; 4 units)

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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

1010, 1024, 1038, 44976, 45509, 45530, 45573, 45583, 45601, 45604, 45619, 45621, 45627, 45639, 45640, 45646, 45655, 45658

1010, 1015, 1034, 1044, 45503, 45537

72444, 72470, 72476, 72480, 72487, 72494, 72515, 72526, 72545

72484, 72490, 72516, 72536