Recall Z-0948-2013— Siemens Medical Solutions USA, Inc

Name: FDA recall Z-0948-2013
Creator: U.S. Food and Drug Administration
Published: 2012-11-27

Class II · Terminated

Class II FDA medical device recall by Siemens Medical Solutions USA, Inc, initiated 2012-11-27, terminated 2014-01-31. It names one FDA 510(k) clearance: K122471. Product: Siemens Somatom CTs equipped with software syngo CT2010A, syngo CT2010B, syngo CT2011A and CT2012B. Computed tomography x-ray system.. Reason: Sporadic hang-up malfunctions concerning 3D reconstructions during activated "Preview Image" functionality..

Recalling firm: Siemens Medical Solutions USA, Inc
Classification: Class II
Status: Terminated
Initiated: 2012-11-27
Terminated: 2014-01-31
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 CTs equipped with software syngo CT2010A, syngo CT2010B, syngo CT2011A and CT2012B. Computed tomography x-ray system.

Reason for recall

Sporadic hang-up malfunctions concerning 3D reconstructions during activated "Preview Image" functionality.

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