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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Search Results for: recall
How Gaps in Requirements Traceability Fuel Recalls and Injuries
Breakdowns in linking requirements to design, risk, and verification are fueling software errors, compliance gaps, and costly recalls across device categories.
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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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Playbook for Managing Connected Medical Devices
A seven-step guide to managing and securing connected medical devices across healthcare delivery organizations.
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