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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Search Results for: recall
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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Baxter’s Life2000 Cyber Recall Draws Attention to FDA’s Focus on Software Safety Risks
A cybersecurity vulnerability that prompted Baxter to recall certain Life2000 ventilators is being seen by some industry experts as part of a broader shift in how the FDA treats software-related risks.
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