Recall Z-2442-2015— Medtronic MiniMed Inc.
Class II · Terminated
Class II FDA medical device recall by Medtronic MiniMed Inc., initiated 2015-07-22, terminated 2015-09-18. FDA's recall record names no specific 510(k) clearance for this event. 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.. 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
- Medtronic MiniMed Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-07-22
- Terminated
- 2015-09-18
- Firm location
- Northridge, CA, United States
Product description
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.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.