Recall Z-1520-2016— Siemens Medical Solutions USA, Inc

Name: FDA recall Z-1520-2016
Creator: U.S. Food and Drug Administration
Published: 2016-03-02

Class II · Terminated

Class II FDA medical device recall by Siemens Medical Solutions USA, Inc, initiated 2016-03-02, terminated 2016-12-13. It names one FDA 510(k) clearance: K121072. Product: Siemens SOMATOM Definition Flash; Intended to produce cross-sectional images of the body. Computed tomography (CT) x-ray system.. Reason: 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 possibly cause the need of additional contrast medium, accidental x-radiation to the user or impede customer workflow..

Recalling firm: Siemens Medical Solutions USA, Inc
Classification: Class II
Status: Terminated
Initiated: 2016-03-02
Terminated: 2016-12-13
Firm location: Malvern, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K121072 — SOMATOM DEFINITION FLASHSiemens Medical Systems, Inc.·cleared 2012-05-08

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

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

Reason for recall

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 possibly cause the need of additional contrast medium, accidental x-radiation to the user or impede customer workflow.

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