Agency classClass IIOur severity:High FDA (Devices)·Z-0325-2025·Announced 2024-11-13

Cardiac stress testing system may assign duplicate exam identifiers to patients

Hillrom Welch Allyn XScribe cardiac stress testing systems may assign duplicate exam identifiers, potentially causing patient data mismatches in medical record systems.

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: This Class II FDA recall involves a theoretical data-integrity hazard with no reported adverse events or injuries. The risk is that duplicate identifiers could cause patient data mismatches if receiving systems rely solely on UIDs, but actual harm has not been documented, placing this at High severity (3) rather than Severe (4).

Plain-English summary

The Hillrom Welch Allyn XScribe Cardiac Stress Testing System is a programmable diagnostic computer used to conduct cardiac stress tests. Approximately 766 units of this system have been distributed worldwide.

The systems may assign duplicate Unique Identifiers (UIDs) to exam files. This could pose a problem if the receiving medical system (such as a Picture Archiving and Communication System, or PACS) relies solely on the UID to match exams to patient records, potentially resulting in mismatches between patient identification and their physiological test data.

This recall affects healthcare facilities and cardiac testing centers using the affected XScribe systems with software versions V6.0.0 or V6.3.2 released July 2, 2015.

The recalled product

Product: Hillrom Welch Allyn XScribe Cardiac Stress Testing System; Programmable Diagnostic Computer
Manufacturer: Baxter Healthcare Corporation
Category: Medical Device — Cardiac Diagnostic Equipment
Hazard: duplicate-identifier
patient-data-mismatch
Affected units: 766

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 V6.3.2
Release Date 02-Jul-2015 Units: 1) UDI/DI 00732094259032
Serial Numbers: 115340269178
117060553883
117060553884
117060553885
119230003169
2) UDI/DI 00732094259070
Serial Numbers: 117130559202
117130559203
117130559204
3) UDI/DI 00732094259100
Serial Numbers: 116270497046
117190567440
4) UDI/DI 00732094259148
Serial Numbers: 117350583961
119060000843
122090000529
5) UDI/DI 00732094259179
Serial Numbers: 116240458434

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