The Recall Desk
HighFDA (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.

What this means for you

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
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 →

Related recalls

Same manufacturer · Baxter Healthcare Corporation

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Same hazard · duplicate identifier

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