Medical device recalls Moderate risk

Siemens Medical Solutions USA, Inc recalls Syngo Imaging VB36D_HF02. Radiological image processing system.

Recall date
October 28, 2015
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0319-2016
FDA classification
Class II
Brand / firm
Siemens Medical Solutions USA, Inc
Sold / distributed
US Distribution to the states of : NC, NE and OH.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Syngo Imaging VB36D_HF02. Radiological image processing system.

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