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Baxter Healthcare Corporation recalls Hillrom Welch Allyn Vision Express Holter Analysis System; Electrocardiograph

Recalled November 13, 2024 · FDA recall Z-0323-2025 · Baxter Healthcare

Hazard
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. · FDA Class II
Units
1003 units
Sold at
Worldwide distribution.

Description

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.

Product
Hillrom Welch Allyn Vision Express Holter Analysis System; Electrocardiograph
Manufacturer(s)
Baxter Healthcare Corporation

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov

Baxter Healthcare Corporation recalls Hillrom Welch Allyn Vision Express Holter Analysis System; Electrocardiograph | RecallWatchUSA