Agency classClass IIOur severity:High FDA (Devices)·Z-0323-2025·Announced 2024-11-13

Electrocardiograph DICOM Files Risk Patient Data Mismatch Due to Duplicate Identifiers

Certain Hillrom Welch Allyn Vision Express Holter Analysis Systems may assign duplicate identifiers to cardiac exam files, risking mismatch between patient identities and their physiological data.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Class II recall with no reported illnesses or injuries. The hazard is potential data integrity failure in a cardiac monitoring device (duplicate UIDs causing patient-data mismatch), qualifying as a risk-of-harm product without reported injury, per Score 3 rubric criteria.

Plain-English summary

Baxter Healthcare Corporation is recalling the Hillrom Welch Allyn Vision Express Holter Analysis System (an electrocardiograph for cardiac monitoring). The affected systems have software versions V6.1.0 through V6.4.1, released August 2, 2016. Approximately 1003 units have been distributed worldwide.

The systems have the potential to assign duplicate Unique Identifiers (UIDs) to cardiac exam files. If a system receiving the DICOM files, such as a Picture Archiving and Communication System (PACS), relies solely on the UID to accept exams, patient identification could be mismatched with their physiological data.

Healthcare facilities using affected equipment should contact Baxter Healthcare Corporation for additional information.

The recalled product

Product: Hillrom Welch Allyn Vision Express Holter Analysis System; Electrocardiograph
Manufacturer: Baxter Healthcare Corporation
Category: Medical Device — Cardiac Monitoring System
Hazard: duplicate-identifier
patient-data-mismatch
Affected units: 1,003

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

Software Versions: Software Version V6.1.0 - V6.4.1
Release Date 02-Aug-2016 Units: 1) UDI/DI 00732094261301
Serial Numbers: 116400529526
116410531595
116420531929
116420532394
116440534958
116440534959
116440534960
116500543068
116510544188
116510544192
116510544191
2) UDI/DI 00812345027051
Serial Numbers: 116410531060
117210570806
115240259136
115350270162
115530286838
116130382969

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 6 recalled by Baxter Healthcare Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 6 products in this recall →

Same manufacturer · Baxter Healthcare Corporation

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Same hazard · duplicate identifier