Recall Z-2264-2012— Siemens Medical Solutions USA, Inc

Name: FDA recall Z-2264-2012
Creator: U.S. Food and Drug Administration
Published: 2012-07-18

Class II · Terminated

Class II FDA medical device recall by Siemens Medical Solutions USA, Inc, initiated 2012-07-18, terminated 2014-11-06. It names one FDA 510(k) clearance: K082430. Product: syngo Imaging XS. Radiological image processing system.. Reason: There is a potential malfunction when using syngo Imaging XS, version VA70A or higher. In some situations it can happen that a miscalculation is done for the grey scale values in the functions "Regions of Interest", "Pixel Lens", "Edge Enhancement" and "Histograms"..

Recalling firm: Siemens Medical Solutions USA, Inc
Classification: Class II
Status: Terminated
Initiated: 2012-07-18
Terminated: 2014-11-06
Firm location: Malvern, PA, United States

510(k) clearances named in this recall

1 on FDA's record

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 Imaging XS. Radiological image processing system.

Reason for recall

There is a potential malfunction when using syngo Imaging XS, version VA70A or higher. In some situations it can happen that a miscalculation is done for the grey scale values in the functions "Regions of Interest", "Pixel Lens", "Edge Enhancement" and "Histograms".

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