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Stellate Systems Recalls
1 recall on record · May 1, 2013 to May 1, 2013 · Medical Devices
May 1, 2013
Medical Devices
FDA
Stellate Systems recalls Harmonie software versions 5.1 uo to 6.2e : Harmonie-E Long Term Monitoring system (Models HSYS-REC-WD, HSYS-REC-WT; HS
Hazard: 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.
Stellate Systems Recalls | RecallWatchUSA