Reported Nov 7, 2018 · Terminated
EVO Excel, Emission Computed Tomographic System, Material Number 10910501
Siemens Medical Solutions USA, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Siemens Medical Solutions USA, Inc. · 2501 Barrington Rd · Hoffman Estates, IL · 60192-2061
Is this the product you have?
- EVO Excel, Emission Computed Tomographic System, Material Number 10910501
- Lot codes and dates
- Serial Numbers
264 of 264 codes
100110021003100410051006100710081009101010111012101310141015101610171018101910201021102210231024102510261027102810291030103110321033103410351036103710381039104010411042104310441045104610471048104910501051105210531054105510561057105810591060
- Serial Numbers
- Amount recalled
- 264 units
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.,
This product could cause temporary or reversible health problems — stop using it.
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