Day

July 11, 2018
Company: Medtronic Inc. Date of Enforcement Report: 7/11/2018 Class II: PRODUCT Medtronic MiniMed Paradigm Vea Insulin Pump Product Catalog Number: MMT-554, MMT-754 Recall Number: Z-2377-2018 REASON Medtronic notified customers/users of MiniMed” Paradigm” Veo” insulin pump that the pump has an error that impacts the Arabic language translation.This translation error occurs in the Predictive Alerts setting...
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Company: GE Healthcare Finland Oy Date of Enforcement Report 7/11/2018 Class II: PRODUCT GE Healthcare CARESCAPE Monitor B650 Recall Number: Z-2340-2018 REASON When multiple CARESCAPE Monitor B650 units are connected to the same network and a network overload occurs for a prolonged time, the monitors may simultaneously restart as designed. The monitor restart will not...
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Company:Medtronic Inc. Date of Enforcement Report 7/11/2018 Class lI: PRODUCT Medtronic MiniMed Paradigm Vea Insulin Pump Product Catalog Number: MMT-554, MMT-754 Recall Number: Z-2377-2018 REASON Medtronic notified customers/users of MiniMed” Paradigm” Veo” insulin pump that the pump has an error that impacts the Arabic language translation.This translation error occurs in the Predictive Alerts setting screen,...
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Company:GE Healthcare Finland Oy Date of Enforcement Report 7/11/2018 Class lI: PRODUCT GE Healthcare CARESCAPE Monitor B650 Recall Number: Z-2340-2018 REASON When multiple CARESCAPE Monitor B650 units are connected to the same network and a network overload occurs for a prolonged time, the monitors may simultaneously restart as designed. The monitor restart will not be...
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Company:Spacelabs Healthcare, Ltd Date of Enforcement Report 8/10/2018 Class l: PRODUCT The Arkon Anesthesia Delivery System is intended for use in hospitals and operating rooms. It may be used to deliver oxygen, air, and nitrous oxide in a controlled manner to various patient breathing circuits (accessory sets that include tubing and breathing bags) with or...
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