Stellate Systems Recalls Harmonie Software Due to FDA Clearance Issues
Stellate Systems is recalling Harmonie software versions 5.1 to 6.2e because the product's labeling indications have not been cleared by the FDA for sale in the USA.
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 is classified as FDA Class II, which typically corresponds to a moderate severity score. The hazard is a regulatory labeling issue rather than a direct physical safety defect or reported injury.
Plain-English summary
Stellate Systems is recalling 2,660 software licenses for Harmonie software versions 5.1 through 6.2e. The affected products include the Harmonie-E Long Term Monitoring system and various associated detectors and readers used in neurological and sleep monitoring applications.
The firm initiated this recall because the implied or stated indications in the product labeling have not yet been cleared by the FDA for sale in the United States. The recall covers products distributed worldwide, including nationwide distribution in the USA and in numerous international countries.
Healthcare facilities and users of these monitoring systems should stop using the affected software versions and contact Stellate Systems for further instructions on remediation or replacement.
The recalled product
- Product
- Harmonie software versions 5.1 uo to 6.2e : Harmonie-E Long Term Monitoring system (Models HSYS-REC-WD, HSYS-REC-WT; HSYS-REC0LT2; HSYS-REC-EAMP) Product in use with Harmonie-E Long Term Monitoring System : ICTA-S & ICTA-D Seizure Detector, Slow wave Seizure Detector…
- Manufacturer
- Stellate Systems
- Category
- Medical Device — Software
- Affected units
- 2,660
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- Models HSYS-REC-WD
- HSYS-REC-WT
- HSYS-REC0LT2
- HSYS-REC-EAMP Model HSYS-REC-DUO-PPC Model HSYS-REC-DUO-PPC Models HSYS-RDR-D
- HSYS-RDR-T
Distribution
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