Recall Z-1622-2014— Siemens Medical Solutions USA, Inc

Name: FDA recall Z-1622-2014
Creator: U.S. Food and Drug Administration
Published: 2014-04-03

Class II · Terminated

Class II FDA medical device recall by Siemens Medical Solutions USA, Inc, initiated 2014-04-03, terminated 2014-12-15. It names 3 FDA 510(k) clearances: K052461, K042832, K033831. Product: syngo Imaging XS Syngo Imaging XS is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. It supports the physician in diagnosis and treatment planning. Syngo Imaging XS also supports storage and archiving of Structured DICOM reports. Syngo Imaging XS optionally uses a variety of advanced postprocessing applications.. Reason: A complaint reported that the archiving method at one customer site was changed from implicit to explicit, and the cleanup procedure enabled by the explicit archivingmethod may have deleted data from archive itself..

Recalling firm: Siemens Medical Solutions USA, Inc
Classification: Class II
Status: Terminated
Initiated: 2014-04-03
Terminated: 2014-12-15
Firm location: Malvern, PA, United States

510(k) clearances named in this recall

3 on FDA's record

K052461 — SYNGO IMAGING VERSION V20ASiemens AG Medical Solutions·cleared 2005-09-22
K042832 — SIENET COSMOS (VERSION V15A)Siemens AG Medical Solutions·cleared 2004-10-28
K033831 — SIENET COSMOSSiemens AG Medical Solutions·cleared 2003-12-19

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

syngo Imaging XS Syngo Imaging XS is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. It supports the physician in diagnosis and treatment planning. Syngo Imaging XS also supports storage and archiving of Structured DICOM reports. Syngo Imaging XS optionally uses a variety of advanced postprocessing applications.

Reason for recall

A complaint reported that the archiving method at one customer site was changed from implicit to explicit, and the cleanup procedure enabled by the explicit archivingmethod may have deleted data from archive itself.

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