TL;DR What Happened? The recalled product is Baxter 0.9% Sodium Chloride Injection USP, 500 mL VIAFLEX Plastic Container, involving identified lots distributed July 31 through August 3 to multiple U.S. states. The company says the potential contaminant was identified as fiberglass. Customers should discontinue use and return affected units. Why…
TL;DR FDA says GE reported that during an update of Portrait Core Services software, some patients monitored using Portrait Mobile devices were discharged removed from the monitoring system. FDA also says alarm settings may reset to factory defaults following the update. That creates the possibility that the hardware appears operational…
FDA has proposed reclassifying digital breast tomosynthesis (DBT) systems from Class III to Class II. If finalized, the change would replace the current PMA framework for these systems with Class II special controls plus 510(k) premarket notification requirements. For manufacturers, this could materially change both new-product submissions and lifecycle-management strategy.…
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