Harmonie software versions 5 — Class II medical device recall Z-1080-2013
Terminated recall by Stellate Systems, reported 2013-05-01, distributed nationwide. The firm is initiating this recall because the implied or stated indications in their labeling associated with
| Recall number | Z-1080-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stellate Systems, Westmount, Canada |
| Recall initiated | 2009-04-06 |
| Classified | 2013-04-22 |
| Reported by FDA | 2013-05-01 |
| Terminated | 2013-04-22 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AU, BH, CA, CH, CN, DE, DK, ES, FI, FR, GB, GR, HK, HT, HU, ID, IL, IR, IT, JP, KR, MX, NL, NO, PA, PK, PT, SA, TH, TR, TW |
| Quantity | 2,660 software |
| Reason classes | labeling, software |
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 Harmonie-S Sleep System: Rapid Eye Movement Detector, Spindle Detector, Heart Rate Processor, Periodic Leg Movement Detector and Oximetry/Pulse rate Threshold Notification VITA/ICU Neurological Monitoring System: Burst Suppression Detector, Cerebral Function Monitor Trend, Visual and Auditory Notifications on all trends graphs in PolyTrends Harmonie {-s}{-E} Readers ,
Reason for recall
The firm is initiating this recall because the implied or stated indications in their labeling associated with Harmonie software have not yet been cleared by the FDA for sale in the USA.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1080-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.