Recall Z-1613-2014— Siemens Medical Solutions USA, Inc

Name: FDA recall Z-1613-2014
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 2 FDA 510(k) clearances: K102150, K023772. Product: Syngo Dynamics v9.5 system. A Picture Archiving and Communication System (PACS) intended for acceptance, transfer, display, storage, archive and manipulation of digital medical images, including quantification and report generation.. Reason: Systems with the affected serial number are experiencing a software error which may lead to incorrect patient demographics display..

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

2 on FDA's record

K102150 — SYNGO DYNAMICS, VERSION 9.0Siemens Medical Solutions USA, Inc.·cleared 2010-10-05
K023772 — KINETDX PICTURE ARCHIVING AND COMMUNICATIONS SYSTEMAcuson Corp.·cleared 2002-11-22

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 Dynamics v9.5 system. A Picture Archiving and Communication System (PACS) intended for acceptance, transfer, display, storage, archive and manipulation of digital medical images, including quantification and report generation.

Reason for recall

Systems with the affected serial number are experiencing a software error which may lead to incorrect patient demographics display.

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