FDA-Device2015-09-02Class II
Guardian Real-Time Monitor, Model No. CSS7100. Indicated for continuous or periodic monitoring of glucose levels in the fluid under the skin, in adults (18 years and older) with diabetes mellitus, for the purpose of improving diabetes management.
Medtronic MiniMed Inc.
Hazard
Medtronic MiniMed is recalling the Guardian Real-Time Continuous Glucose Monitoring System because it has a language translation error that impacts the Finnish language. Specifically, the Monitor has a Finnish translation error in Predictive Alerts setting: the on-screen Finnish translation for LOW/HIGH is reversed as HIGH/LOW.
Sold states
Distributed in Finland.
Affected count
254 units
Manufactured in
18000 Devonshire St, N/A, Northridge, CA, United States
Products
Guardian Real-Time Monitor, Model No. CSS7100. Indicated for continuous or periodic monitoring of glucose levels in the fluid under the skin, in adults (18 years and older) with diabetes mellitus, for the purpose of improving diabetes management.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2442-2015Don't want to check this manually?
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