Recall Z-1518-2016— Siemens Medical Solutions USA, Inc

Name: FDA recall Z-1518-2016
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: K122471. Product: Siemens SOMATOM Definition: 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, 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..

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

K122471 — SOMATOM DEFINITIONSiemens Medical Systems, Inc.·cleared 2012-09-11

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: 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, 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.

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