Recall Z-1027-2015— Siemens Medical Solutions USA, Inc

Name: FDA recall Z-1027-2015
Creator: U.S. Food and Drug Administration
Published: 2015-01-13

Class II · Terminated

Class II FDA medical device recall by Siemens Medical Solutions USA, Inc, initiated 2015-01-13, terminated 2017-02-16. It names 3 FDA 510(k) clearances: K132532, K093612, K955394. Product: Syngo.plaza: Syngo.plaza 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.plaza also supports storage and archiving of DICOM Structured reports. In a comprehensive imaging syngo.plaza integrates Hospital/Radiology Information Systems (HIS/RIS) to enable customer specific workflows. Syngo.plaza optionally uses a variety of advanced postprocessing applications. Reason: In case of a system crash, images may not be written to the hard disk and this may result in inconsistencies in the database. In case of a system crash (e.g. blue screen, power outage) images may not be written from cache to the hard disk and might get lost..

Recalling firm: Siemens Medical Solutions USA, Inc
Classification: Class II
Status: Terminated
Initiated: 2015-01-13
Terminated: 2017-02-16
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
K955394 — SIENET TELERADIOLOGY PRODUCT LINESiemens Medical Solutions USA, Inc.·cleared 1996-02-21

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 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.plaza also supports storage and archiving of DICOM Structured reports. In a comprehensive imaging syngo.plaza integrates Hospital/Radiology Information Systems (HIS/RIS) to enable customer specific workflows. Syngo.plaza optionally uses a variety of advanced postprocessing applications

Reason for recall

In case of a system crash, images may not be written to the hard disk and this may result in inconsistencies in the database. In case of a system crash (e.g. blue screen, power outage) images may not be written from cache to the hard disk and might get lost.

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