Recall Z-0576-2015— Siemens Medical Solutions USA, Inc

Name: FDA recall Z-0576-2015
Creator: U.S. Food and Drug Administration
Published: 2014-11-11

Class II · Terminated

Class II FDA medical device recall by Siemens Medical Solutions USA, Inc, initiated 2014-11-11, terminated 2015-02-24. It names 3 FDA 510(k) clearances: K132532, K093612, K082430. Product: Syngo.plaza, Syngo.plaza VB10A, and syngo Imaging XS : Product Usage: Syngo.plaza is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images.. Reason: Printouts may be printed in incorrect anatomical size when using syngo.plaza or syngo Imaging XS filming application in conjunction with a printer not released for anatomical print usage. This may happen due to an invalid combination of printer and the syngo.plaza printer configuration file. Printouts in anatomical size are not correct and may influence diagnostic decisions and/or therapy..

Recalling firm: Siemens Medical Solutions USA, Inc
Classification: Class II
Status: Terminated
Initiated: 2014-11-11
Terminated: 2015-02-24
Firm location: Malvern, PA, United States

510(k) clearances named in this recall

3 on FDA's record

K132532 — SYNGO.PLAZA VB10ASiemens AG Healthcare·cleared 2013-12-09
K093612 — SYNGO.PLAZASiemens AG Medical Solutions·cleared 2010-03-04
K082430 — SYNGO IMAGING XSSiemens AG Medical Solutions·cleared 2008-11-14

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.plaza, Syngo.plaza VB10A, and syngo Imaging XS : Product Usage: Syngo.plaza is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images.

Reason for recall

Printouts may be printed in incorrect anatomical size when using syngo.plaza or syngo Imaging XS filming application in conjunction with a printer not released for anatomical print usage. This may happen due to an invalid combination of printer and the syngo.plaza printer configuration file. Printouts in anatomical size are not correct and may influence diagnostic decisions and/or therapy.

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