FDA-Device2024-11-13Class II
Hillrom Welch Allyn Vision Express Holter Analysis System; Electrocardiograph
Baxter Healthcare Corporation
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.
Sold states
Worldwide distribution.
Affected count
1003 units
Manufactured in
1 Baxter Pkwy, N/A, Deerfield, IL, United States
Products
Hillrom Welch Allyn Vision Express Holter Analysis System; Electrocardiograph
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0323-2025Don't want to check this manually?
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