Fresenius Medical Care Holdings, Inc.: Dialyzer, High Permeability With Or Without Sealed Dialysate System

Several software anomalies with the potential to impact patient treatment, of which one includes the possibility to result in treatment stop if certain conditions are fulfilled.

Tags

FDA recall, medical device, class 2, Gastroenterology, Urology, Software design, Open, Classified

Related exam domains

CISSP 3: Security Architecture and Engineering; CISSP 8: Software Development Security

Source record id

Z-0936-2026

First seen by InfoSec Signals

Sep 23, 2026

Source: openFDA device recalls, U.S. Food and Drug Administration · about this source · more from it

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