Siemens Medical Solutions USA, Inc: Siemens is releasing a software update that provides bug-fixes to improve system performance for customers with SOMATOM Definition AS, SOMATOM Definition Edge, SOMATOM Definition Flash Systems with software version VA48A_SP2 and Care Contrast license correction of potential safety issues.

Agency Publication Date: November 17, 2016

Affected Products

Product: SOMATOM Definition AS, Computed tomography x-ray system The Siemens SOMATOM Definition AS/ AS+ (Project P46) systems are intended to produce 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

Model Number: 8098027 Serial Numbers:96020, 96047,74192,83398,96011,83387 96029

Product: SOMATOM Definition Edge, Computed tomography x-ray system The Siemens SOMATOM Definition AS/ AS+ (Project P46) systems are intended to produce 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

Model Number: 1059000 Serial Numbers:96020, 96047,74192,83398,96011,83387 96029

Product: SOMATOM Definition Flash, Computed tomography x-ray system The Siemens SOMATOM Definition AS/ AS+ (Project P46) systems are intended to produce 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

Model Number: 10430603 Serial Numbers:96020, 96047,74192,83398,96011,83387 96029

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 75677

Status: Resolved

Manufacturer: Siemens Medical Solutions USA, Inc

Manufactured In: United States

Units Affected: 3 products (7 systems)

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.

Affected Products

Model Number: 8098027 Serial Numbers:96020, 96047,74192,83398,96011,83387 96029

Model Number: 1059000 Serial Numbers:96020, 96047,74192,83398,96011,83387 96029

Model Number: 10430603 Serial Numbers:96020, 96047,74192,83398,96011,83387 96029