FDA Alerts Users to Purge Pressure Issues in Automated Impella Controller
The alert links purge retainer failures to potential pump stops and loss of hemodynamic support; the manufacturer is planning a service update.
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Search Results for: recall
Class I Recall Expanded for Alaris Pump Infusion Sets
The voluntary recall involves certain infusion sets used with the BD Alaris Pump Module model 8100 due to performance deviations that could impact dose accuracy.
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Tandem Issues Correction for t:slim X2 Insulin Pumps
A faulty speaker wire can cause a malfunction that halts insulin delivery, prompting the US Food and Drug Administration to classify the action as a Class I recall.
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Philips Recalls Reworked CPAP and BiPAP Devices Over Programming Error
Philips Respironics is recalling certain DreamStation Auto CPAP and Auto BiPAP devices due to a programming error introduced during rework by a supplier.
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FDA OKs MiniMed 780G for Type 2 Diabetes and Approves Integration With Abbott Sensor
The automated insulin delivery system is now approved for adults with type 2 diabetes and cleared for interoperability with Abbott’s Instinct sensor for type 1 diabetes.
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