FDA Flags Defibrillator Lead Issue Linked to Serious Injuries, Deaths
Boston Scientific’s Endotak Reliance leads with ePTFE-coated coils may reduce shock efficacy due to coil calcification.
Boston Scientific’s Endotak Reliance leads with ePTFE-coated coils may reduce shock efficacy due to coil calcification.
Customers are being asked to remove the affected devices from use and replace with an alternate means of ventilation.
BD is correcting software for its Alaris Systems Manager and CCE Infusion Adapter after identifying a risk that outdated infusion parameters could be uploaded, potentially leading to incorrect dosing.
Boston Scientific’s Endotak Reliance leads with ePTFE-coated coils may reduce shock efficacy due to coil calcification.
Philips’ cardiac telemetry Monitoring Service Application did not route some ECG events from July 2022 to July 2024 for cardiology review.
Read MoreBaxter is recalling certain Solution Sets with Duo-Vent Spikes due to an assembly issue that led to inverted slide clamps.
Read MorePhilips has updated instructions for several ventilators to address aerosol deposits on internal sensors when used with in-line nebulizers.
Read MorePercussionaire is recalling Phasitron 5 breathing circuits due to a nickel coating issue that may aerosolize nickel and pose health risks. Customers are advised to dispose of or return affected products, with specific short-term use guidelines for necessary situations.
Read MoreGE HealthCare has issued an update to the EVair Compressor recall, with testing results confirming safe usage across all patient groups.
Read MoreFresenius Kabi recalled a specific lot of Ivenix LVP Primary Administration Sets due to a defect that could cause uncontrolled flow.
Read MoreSmiths Medical has issued an urgent notification for certain Bivona Tracheostomy Tubes due to a defect that may cause improper ventilation.