Siemens EVO Excel CT System Recalled for Mis-Labeled Current Limit
Siemens Medical Solutions is recalling 264 EVO Excel CT systems because the external ECG power-connection current limit is mis-labeled as 1.0A instead of 0.55A.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall involves a minor labeling error on a medical device where no injuries or illnesses are reported, fitting the criteria for a moderate severity score.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 264 units of the EVO Excel Emission Computed Tomographic System (Material Number 10910501). The recall was initiated because the current limit for the External-ECG Power-Connection is mis-labeled as 1.0A, whereas it should be labeled as 0.55A.
The affected units were distributed worldwide. The source text does not specify the exact number of reported injuries or illnesses associated with this labeling error.
Healthcare facilities should contact Siemens Medical Solutions USA, Inc. for instructions on how to correct the labeling on the affected systems.
The recalled product
- Product
- EVO Excel, Emission Computed Tomographic System, Material Number 10910501
- Manufacturer
- Siemens Medical Solutions USA, Inc.
- Hazard
- Affected units
- 264
Distribution
Distribution scope not specified by the agency.
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