Medical device recalls Moderate risk

Siemens Medical Solutions USA, Inc recalls MAGNETOM Aera/Skyra Systems, whole body magnetic resonance imaging systems, Model numbers 10432914, 10432915. Docking s…

Recall date
April 13, 2016
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1598-2016
FDA classification
Class II
Brand / firm
Siemens Medical Solutions USA, Inc
Sold / distributed
US nationwide distribution to OH, FL, TN, MN, OH, NY, VA, and MN.

Why it was recalled

The docking station top cover of the removable patient table may contain a magnetic metal plate. When docking/undocking the table, the magnetic top cover may become attracted to the magnet.

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

What was recalled

MAGNETOM Aera/Skyra Systems, whole body magnetic resonance imaging systems, Model numbers 10432914, 10432915. Docking station top cover (part no# 10591430) of the removable patient table.

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