Medical device recalls Moderate risk

Siemens Medical Solutions USA, Inc recalls SOMATOM Perspective, Computed tomography x-ray system

Recall date
November 22, 2016
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0921-2017
FDA classification
Class II
Brand / firm
Siemens Medical Solutions USA, Inc
Sold / distributed
Distributed to: IL IL GA SC SD OK NY MI IN MD AR

Why it was recalled

Siemens is providing a new installation of the Residual Current Monitor (RCM) in the Line Connection Box (LCB) to resolve a potential defect that could lead to a power cutout during use of the SOMATOM Scope, Scope Power and Perspective systems.

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

What was recalled

SOMATOM Perspective, Computed tomography x-ray system

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