Recall Z-1975-2013— Siemens Medical Solutions USA, Inc

Name: FDA recall Z-1975-2013
Creator: U.S. Food and Drug Administration
Published: 2013-03-04

Class II · Terminated

Class II FDA medical device recall by Siemens Medical Solutions USA, Inc, initiated 2013-03-04, terminated 2015-03-09. It names one FDA 510(k) clearance: K093612. Product: Siemens syngo.plaza SW version VA20 with Mammography license. image processing, radiological system. Reason: Siemens issued a Customer Safety Notice to inform customers of a potential problem when using syngo.plaza. In some instances, it can happen that the laterality information in mammography images is not displayed and these images may not be properly aligned to mammography segments..

Recalling firm: Siemens Medical Solutions USA, Inc
Classification: Class II
Status: Terminated
Initiated: 2013-03-04
Terminated: 2015-03-09
Firm location: Malvern, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K093612 — SYNGO.PLAZASiemens AG Medical Solutions·cleared 2010-03-04

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 syngo.plaza SW version VA20 with Mammography license. image processing, radiological system

Reason for recall

Siemens issued a Customer Safety Notice to inform customers of a potential problem when using syngo.plaza. In some instances, it can happen that the laterality information in mammography images is not displayed and these images may not be properly aligned to mammography segments.

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