Recall Z-0608-2017— Siemens Medical Solutions USA, Inc

Name: FDA recall Z-0608-2017
Creator: U.S. Food and Drug Administration
Published: 2016-11-02

Class II · Terminated

Class II FDA medical device recall by Siemens Medical Solutions USA, Inc, initiated 2016-11-02, terminated 2017-11-08. It names one FDA 510(k) clearance: K143416. 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. Reason: 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..

Recalling firm: Siemens Medical Solutions USA, Inc
Classification: Class II
Status: Terminated
Initiated: 2016-11-02
Terminated: 2017-11-08
Firm location: Malvern, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K143416 — SOMATOM Definition Flash (VA48)Siemens Medical Solutions USA, Inc.·cleared 2015-04-16

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.