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
- Hazard
- duplicate-identifier
- patient-identification-mismatch
- data-integrity
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.
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