Baxter Healthcare Corporation recalls Hillrom Welch Allyn Q-Stress Cardiac Stress Testing System; cardiac stress test

Recall date

October 11, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0321-2025

FDA classification

Class II

Brand / firm

Baxter Healthcare Corporation

Sold / distributed

Worldwide distribution.

Why it was recalled

There is the potential for exam files being assigned duplicate Unique Identifiers (UIDs),. If the system receiving the DICOM file (e.g., Picture Archiving and Communication System (PACS)) relies solely on the UID to accept exams, this could lead to a mismatch of the patients identification with their physiological data.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Hillrom Welch Allyn Q-Stress Cardiac Stress Testing System; cardiac stress test