The Recall Desk
HighFDA (Devices)·Z-0322-2025·Announced 2024-11-13

Electrocardiograph System May Assign Duplicate Identifiers to Patient Exams

The Hillrom Welch Allyn RScribe 12-Lead Electrocardiograph System may assign duplicate file identifiers that could cause patient data to be mismatched in DICOM archive systems.

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: This is an FDA Class II medical device recall involving a risk-of-harm product where patient data integrity could be compromised. No illnesses or injuries have been reported. Per the rubric, this meets the criteria for High severity: risk-of-harm products where injury has not yet been reported.

Plain-English summary

The Hillrom Welch Allyn RScribe 12-Lead Electrocardiograph System is subject to an FDA Class II recall. Approximately 399 units have been distributed worldwide. The issue affects software versions V6.0.0, V6.2.3 (released July 2, 2015), and V7.0.0 (released October 2, 2017).

The system may assign duplicate Unique Identifiers (UIDs) to exam files. If a DICOM-receiving system, such as a Picture Archiving and Communication System (PACS), relies solely on the UID to identify exams, the presence of duplicate identifiers could cause patient identification to become mismatched with the corresponding physiological data.

Facilities using the affected electrocardiograph systems should contact Baxter Healthcare Corporation regarding this issue.

The recalled product

Product
Hillrom Welch Allyn RScribe 12-Lead Electrocardiograph System; Electrocardiograph
Manufacturer
Baxter Healthcare Corporation
Category
Medical Device — Electrocardiograph / Diagnostic Imaging
Hazard
Affected units
399

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 V6.0.0 V6.2.3
  • Release Date 02-Jul-2015
  • Software Version V7.0.0
  • Release Date 02-Oct-2017 Units: 1) UDI/DI 00732094262957
  • Serial Numbers: 118100617841
  • 118250001722
  • 118480000511
  • 119140000676
  • 119150000331
  • 119180000544
  • 119180000545
  • 119180000546
  • 119180000547
  • 119180000548
  • 119180000549
  • 119180000550
  • 119180000551
  • 119340002011
  • 119340002012
  • 119460000996

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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