Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2442-2015 — 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.

U.S. FDA — Device Enforcement · United States · 2015-07-22 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2442-2015
Date of alert: 2015-07-22
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Medtronic MiniMed Inc.
Product category: device
Product type: Devices

Reported risk: 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.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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Recall Z-2442-2015 — 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.

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