Cl II Guardian Real-Time Monitor

Company:Medtronic MiniMed Inc..
Date of Enforcement Report: 9/2/2015
Class lI:

PRODUCT

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.
Recall Number Z-2442-2015

REASON
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.

RECALLING FIRM/MANUFACTURER
Medtronic MiniMed Inc., Northridge, CA on 7/22/2015 Voluntary: Firm Initiated recall is ongoing

VOLUME OF PRODUCT IN COMMERCE
254 units

DISTRIBUTION
Finland

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15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.