The Recall Desk
HighFDA (Devices)·Z-0320-2025·Announced 2024-11-13

Hillrom HScribe Holter System cardiac monitoring devices duplicate identifier risk

Hillrom HScribe Holter System monitoring devices may assign duplicate file identifiers, risking patient identification mismatches in medical systems that use the identifier to match patient data to cardiac recordings.

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 a Class II medical device recall involving a risk-of-harm scenario where duplicate file identifiers could cause incorrect patient identification with cardiac physiological data. No illnesses or injuries have been reported. The hazard is theoretical (potential for mismatch), and the product is cardiac monitoring equipment where data integrity directly affects patient safety.

Plain-English summary

The Hillrom HScribe Holter System is an ambulatory cardiac monitoring device designed to record heart activity. The FDA has issued a recall for 599 units distributed worldwide due to a software issue where exam files may be assigned duplicate Unique Identifiers (UIDs).

When medical systems such as Picture Archiving and Communication System (PACS) receive DICOM files from the device, they may rely on the unique identifier to match exams with patient records. If duplicate identifiers are generated, the system could fail to correctly associate patient identification with their physiological data, potentially resulting in cardiac recordings being matched to the wrong patient.

Patients or healthcare providers using affected devices should contact Baxter Healthcare Corporation for device replacement or software updates. Specific serial numbers and affected software versions (V4.0.0-V4.34 and V6.1.0-V6.4.1) are identified in the recall notice.

The recalled product

Product
Hillrom Welch Allyn HScribe Holter System; ambulatory monitoring
Manufacturer
Baxter Healthcare Corporation
Category
Medical Device — Cardiac Monitoring / Holter Monitor
Hazard
Affected units
599

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 V4.0.0 V4.34
  • release date 26-Oct-2005
  • Software Version V6.1.0 V6.4.1
  • release date 02-Aug-2016 Units: 1) UDI/DI 00732094263992
  • Serial Numbers: 119470002280
  • 2) UDI/DI 00732094264043
  • Serial Numbers: 112320127784
  • 113500186660
  • 114300222272
  • 115350270164
  • 116490541266
  • 117360584925
  • 117440592623
  • 117440592624
  • 117440592625
  • 117510602023
  • 118330000138
  • 118180634304
  • 118480000469
  • 3) UDI/DI 00732094264074

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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