FDA-Device2018-11-07Class II
EVO Excel, Emission Computed Tomographic System, Material Number 10910501
Siemens Medical Solutions USA, Inc.
Hazard
The Evo Excel External-ECG Power-Connection current limit is mis-labeled as 1.0A. It should be labeled 0.55A.,
Sold states
Worldwide
Affected count
264 units
Manufactured in
2501 Barrington Rd, N/A, Hoffman Estates, IL, United States
Products
EVO Excel, Emission Computed Tomographic System, Material Number 10910501
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0372-2019Don't want to check this manually?
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