Class II

Medical Device Recall: Hillrom Welch Allyn HScribe Holter System; ambulatory monitoring

Baxter Healthcare Corporation · October 11, 2024

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.

Distribution

Worldwide distribution.

Quantity Affected

599 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-0320-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.