PIE Medical Imaging B.V.: Automated Radiological Image Processing Software

User measurement value reported by diagnostic bioimaging software intended to measure/visualize cardiovascular structures may be larger (0.8% to 34.4%) than the actual anatomical dimension, if all the following occur: affected software is used, and the user has access only to 3D Echo OR Mitral 3D Echo, and the dataset being analyzed is a Philips 3D echo dataset containing Color Doppler information

Tags

FDA recall, medical device, class 2, Radiology, Software change control, Open, Classified

Related exam domains

CISSP 3: Security Architecture and Engineering; CISSP 8: Software Development Security; CISM 3: Information Security Program

Source record id

Z-2767-2026

First seen by InfoSec Signals

Sep 23, 2026

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

Exam domain labels come from a keyword heuristic and are study hints, not an official mapping. The summary is the publisher's own text, shortened; the linked record is authoritative.