Harmonie software in use with: Harmonie-E Long Term Monitoring System (Models HSYS-REC-WD, HSYS-REC-WT; HSYS-REC-LT2; HS

FDA device recall Z-0487-2012 · posted 2012-01-11 · Terminated

Recall details

Recalling firm

Stellate Systems

Reason for recall

The following implied or stated indications in Stellate labeling with Harmoniae software have not yet been cleared by the Food and Drug Administration (FDA) for sale in the United States of America.

Action taken

Stellate Systems sent a "DEVICE CORRECTION" letter dated April 6, 2009 to all affected customers. The letter described the product, problem, and the actions to be taken by the customers. The firm provided information on how to verify if customers had the affected product. Software updates will be available to all customers in possession of the affected product. Customers were instructed to call the Customer Support line at 1-888-742-1306 with any questions or concerns they may have regarding the notification.

Root cause

No Marketing Application

Status

Terminated

Product code

GWQ

Quantity affected

1,041 units

Distribution

Worldwide Distribution-USA (nationwide) and the countries of Australia, Canada, Denmark, Greece, Hong Kong, Hungary, Italy, Japan, Mexico, Norway, Rep. DE Panama, Spain, Switzerland, Taiwan ROC, and T

Date initiated

2009-04-16

Date posted

2012-01-11

Date terminated

2011-12-27

Location

Westmount, Canada