Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0323-2025 — Hillrom Welch Allyn Vision Express Holter Analysis System; Electrocardiograph

U.S. FDA — Device Enforcement · United States · 2024-10-11 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0323-2025
Date of alert
2024-10-11
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Baxter Healthcare Corporation
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00732094261301
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.