Recall Z-0907-2014— Siemens Medical Solutions USA, Inc

Name: FDA recall Z-0907-2014
Creator: U.S. Food and Drug Administration
Published: 2013-11-15

Class II · Terminated

Class II FDA medical device recall by Siemens Medical Solutions USA, Inc, initiated 2013-11-15, terminated 2015-03-10. It names 4 FDA 510(k) clearances: K122471, K120579, K113342 and 1 more. Product: Siemens SOMATOM Definition, Definition AS, Definition Flash, and Definition Edge systems. X-ray tomography, computed, radiology.. Reason: During clinical operation, a malfunction may occur causing a system display freeze with SOMATOM Definition, Definition AS, and definition Edge while running software version syngo CT2012 B and syngo CT2013B..

Recalling firm: Siemens Medical Solutions USA, Inc
Classification: Class II
Status: Terminated
Initiated: 2013-11-15
Terminated: 2015-03-10
Firm location: Malvern, PA, United States

510(k) clearances named in this recall

4 on FDA's record

K122471 — SOMATOM DEFINITIONSiemens Medical Systems, Inc.·cleared 2012-09-11
K120579 — SOMATOM DEFINITION EDGESiemens Medical Systems, Inc.·cleared 2012-05-23
K113342 — SOMATOM DEFINITION FLASHSiemens Medical Systems, Inc.·cleared 2011-12-29
K103127 — SOMATOM DEFINITION ASSiemens Medical Solutions USA, Inc.·cleared 2011-03-04

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, Definition AS, Definition Flash, and Definition Edge systems. X-ray tomography, computed, radiology.

Reason for recall

During clinical operation, a malfunction may occur causing a system display freeze with SOMATOM Definition, Definition AS, and definition Edge while running software version syngo CT2012 B and syngo CT2013B.

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