Recall Z-0323-2025— Baxter Healthcare Corporation

Name: FDA recall Z-0323-2025
Creator: U.S. Food and Drug Administration
Published: 2024-10-11

Class II · Ongoing

Class II FDA medical device recall by Baxter Healthcare Corporation, initiated 2024-10-11. It names one FDA 510(k) clearance: K004017. Product: Hillrom Welch Allyn Vision Express Holter Analysis System; Electrocardiograph. Reason: 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..

Recalling firm: Baxter Healthcare Corporation
Classification: Class II
Status: Ongoing
Initiated: 2024-10-11
Firm location: Deerfield, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K004017 — H-SCRIBEMortara Instrument, Inc.·cleared 2001-06-11

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Hillrom Welch Allyn Vision Express Holter Analysis System; Electrocardiograph

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.