Philips Issues Correction for Trilogy Evo Ventilators Following FDA Class I Recall
The Food and Drug Administration identifies the software update and nebulizer restrictions as the most serious type of recall.
Category: Recalls
Recalls
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Recalls
Latest
FDA Issues Recall Early Alert for Olympus Single-Use Ligating Devices
Olympus has updated use instructions after reports that the ligation loop may not release as expected, potentially requiring emergency intervention.
Recalls
Latest
3M Company Corrects Ranger Blood/Fluid Warming System
The action addresses a discrepancy between the device's labeled and actual performance at high flow rates, which could pose a risk of patient hypothermia.
Recalls
Latest
Philips Issues Correction for Trilogy Evo Ventilators Following FDA Class I Recall
The Food and Drug Administration identifies the software update and nebulizer restrictions as the most serious type of recall.
FDA Issues Class I Recall for Ambu Manual Resuscitators
The most serious type of recall was initiated due to a blocked manometer port, which can prevent pressure monitoring and lead to severe patient harm.
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FDA Announces Class I Recall for ICU Medical Infusion Pump
A software flaw that may cause the Plum Duo Infusion System to become unresponsive has prompted a device correction, which the FDA has identified as its most serious recall type.
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Hamilton Medical Corrects C6 Ventilators Over Circuit Board Defect
The FDA has issued a Class I recall designation for the correction, which addresses a fault that can cause ventilation to stop unexpectedly.
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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.
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Philips Respironics Updates Use Instructions for Certain BiPAP Devices
Updated guidance addresses ventilator inoperative alarm failures that may lead to therapy loss, with 13 injuries and eight deaths reported.
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FDA Issues Early Alert on Infusion Pump Issue from Baxter
The FDA issued an early alert under its recall communications pilot citing 79 injuries and two deaths linked to Baxter’s Novum IQ infusion pump.
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Recalls
Latest
BD Recalls Alaris Pump Modules Serviced With Previously Recalled Parts
The voluntary recall involves pump modules that may have been repaired with FR-110 bezels, which the company says can weaken over time and compromise safe infusion delivery.
