Recall Z-0319-2016— Siemens Medical Solutions USA, Inc

Name: FDA recall Z-0319-2016
Creator: U.S. Food and Drug Administration
Published: 2015-10-28

Class II · Terminated

Class II FDA medical device recall by Siemens Medical Solutions USA, Inc, initiated 2015-10-28, terminated 2016-10-06. It names 2 FDA 510(k) clearances: K081734, K071114. Product: Syngo Imaging VB36D_HF02. Radiological image processing system.. Reason: To provide supplementary information regarding the release of the syngo Imaging Software Version VB36D_HF02. The software provides improvements for all syngo Imaging installations running on the software Version VB36D..

Recalling firm: Siemens Medical Solutions USA, Inc
Classification: Class II
Status: Terminated
Initiated: 2015-10-28
Terminated: 2016-10-06
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

Syngo Imaging VB36D_HF02. Radiological image processing system.

Reason for recall

To provide supplementary information regarding the release of the syngo Imaging Software Version VB36D_HF02. The software provides improvements for all syngo Imaging installations running on the software Version VB36D.

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