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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