Siemens Medical Solutions USA, Inc: Software bugs in these SOMATOM systems could possibly cause scan aborts, re-scans of patients with additional dose, delayed diagnosis and as worst case scenarios, could possibly cause the need of additional contrast medium, accidental x-radiation to the user or impede customer workflow.; Software bugs in these SOMATOM systems could possibly cause scan aborts, rescans of patients with additional dose, delayed diagnosis and as worst case scenarios, could possibl

Agency Publication Date: April 19, 2016

Affected Products

Product: Siemens SOMATOM Definition: Intended to produce cross-sectional images of the body. Computed tomography (CT) x-ray system.

Model Number: 7740769 SOMATOM Definition family of CT systems running on software versions VA44A_SP3a, VA44A_SP3b, VA44A_SP3c.

Product: Siemens SOMATOM Definition AS; Intended to produce cross-sectional images of the body. Computed tomography (CT) x-ray system.

Model Number: 8098027 SOMATOM Definition family of CT systems running on software versions VA44A_SP3a, VA44A_SP3b, VA44A_SP3c.

Product: Siemens SOMATOM Definition Flash; Intended to produce cross-sectional images of the body. Computed tomography (CT) x-ray system.

Model Number: 10430603 SOMATOM Definition family of CT systems running on software versions VA44A_SP3a, VA44A_SP3b, VA44A_SP3c.

Product: Siemens SOMATOM Definition, SOMATOM Definition AS, SOMATOM Definition Flash and SOMATOM Definition Edge; Intended to produce cross-sectional images of the body. Computed tomography (CT) x-ray system.

Model Number: 10590000 SOMATOM Definition family of CT systems running on software versions VA44A_SP3a, VA44A_SP3b, VA44A_SP3c.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 73593

Status: Resolved

Manufacturer: Siemens Medical Solutions USA, Inc

Manufactured In: United States

Units Affected: 4 products (1096)

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Sources: FDA iRES · Raw API Response

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