Recall Z-1349-2016— Siemens Medical Solutions USA, Inc

Name: FDA recall Z-1349-2016
Creator: U.S. Food and Drug Administration
Published: 2016-01-18

Class II · Terminated

Class II FDA medical device recall by Siemens Medical Solutions USA, Inc, initiated 2016-01-18, terminated 2017-08-03. It names 2 FDA 510(k) clearances: K081734, K071114. Product: A Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images, including digital mammography images.. Reason: To inform users about the possible incorrect values for Distance Measurements when using certain modalities in combination with syngo Imaging..

Recalling firm: Siemens Medical Solutions USA, Inc
Classification: Class II
Status: Terminated
Initiated: 2016-01-18
Terminated: 2017-08-03
Firm location: Malvern, PA, United States

510(k) clearances named in this recall

2 on FDA's record

K081734 — SYNGO IMAGING (VERSION V31)Siemens AG Medical Solutions·cleared 2008-07-03
K071114 — SYNGO IMAGING (VERSION V30)Siemens AG Medical Solutions·cleared 2007-05-22

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

A Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images, including digital mammography images.

Reason for recall

To inform users about the possible incorrect values for Distance Measurements when using certain modalities in combination with syngo Imaging.

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