Drug recall
Harmonie software versions 5.1 uo to 6.2e: Harmonie-E Long Term Monitoring system (Models HSYS-REC-WD…
FDA recall event 64594 · Class II · Stellate Systems
Key facts
| Event ID | 64594 |
|---|---|
| Recall numbers | Z-1080-2013 |
| Recalling firm | Stellate Systems |
| Product type | Devices |
| Products | 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… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| 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. |
| Initiation date | Apr 6, 2009 |
| Report date | May 1, 2013 |
| Termination date | Apr 22, 2013 |
| City | Westmount |
| Country | Canada |
| FEI number | 3002808695 |
At a glance
- 1–9 Products in this recall
- None FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: