Medical device recalls Moderate risk

Siemens Medical Solutions USA, Inc. recalls EVO Excel, Emission Computed Tomographic System, Material Number 10910501

Recall date
October 5, 2018
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0372-2019
FDA classification
Class II
Brand / firm
Siemens Medical Solutions USA, Inc.
Sold / distributed
Worldwide

Why it was recalled

The Evo Excel External-ECG Power-Connection current limit is mis-labeled as 1.0A. It should be labeled 0.55A.,

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

What was recalled

EVO Excel, Emission Computed Tomographic System, Material Number 10910501

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