AI Chatbots Top Annual List of Health Technology Hazards
ECRI’s report also sounds the alarm on insufficient planning for systems outages, substandard medical products, missed recalls of home diabetes management devices, and more.
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Search Results for: recall
GAO Report Finds FDA Struggles to Meet Medical Device Recall Termination Goals
The agency exceeded its three-month termination timeline for 74% of recalls during fiscal years 2020-2024, due to staff constraints that limited oversight activities, the report finds.
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FDA Clears Multi-Modality Breast Biopsy and Tissue Removal System
The newly cleared system is designed to support breast biopsy procedures across multiple imaging modalities using a single platform.
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Fresenius Kabi Removes Ivenix Large-Volume Pumps
A misassembly defect in a specific lot of Ivenix primary administration sets could cause reverse flow, delayed infusion, or serious patient harm, prompting a Class I recall.
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Baxter Removes Sigma Spectrum Infusion System Platforms
The removal is tied to incorrect software installations that could result in inaccurate flow rates and user confusion during clinical use.
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