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Open, Classified

Hillrom Welch Allyn HScribe Holter System; ambulatory monitoring

FDA Recall Z-0320-2025 · Posted 2024-11-07

Recalling FirmBaxter Healthcare Corporation
Recall StatusOpen, Classified
Product CodeMLO
Date Initiated2024-10-11
Product Quantity599 units

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.

Firm Action

Baxter issued an URGENT MEDICAL DEVICE CORRECTION notice to its consignees on 10/11/2024 via USPS First Class Mail. The notice explained the issue, potential hazard to the patient, and provided instructions for the to the system IT administrator to correct the issue which is already available in the current version of software.

Root Cause

Software design

Distribution Pattern

Worldwide distribution.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K004017H-SCRIBEMortara Instrument, Inc. · 2001-06-11

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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