Recall Z-0048-2013— Siemens Medical Solutions USA, Inc

Name: FDA recall Z-0048-2013
Creator: U.S. Food and Drug Administration
Published: 2012-06-06

Class II · Terminated

Class II FDA medical device recall by Siemens Medical Solutions USA, Inc, initiated 2012-06-06, terminated 2013-04-13. It names one FDA 510(k) clearance: K093612. Product: Siemens syngo.plaza radiological image processing system.. Reason: Siemens became aware of an unintended behavior when using syngo.plaza. In syngo.plaza within the online "Short Time Storage" (STS), some studies are marked with an archived icon, however, the entry in the Archive Database referring to the physical file may be missing..

Recalling firm: Siemens Medical Solutions USA, Inc
Classification: Class II
Status: Terminated
Initiated: 2012-06-06
Terminated: 2013-04-13
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 radiological image processing system.

Reason for recall

Siemens became aware of an unintended behavior when using syngo.plaza. In syngo.plaza within the online "Short Time Storage" (STS), some studies are marked with an archived icon, however, the entry in the Archive Database referring to the physical file may be missing.

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