Agency classClass IIOur severity:High FDA (Devices)·Z-0734-2025·Announced 2025-01-01

Blood Analysis System Recalled Due to Patient Name Assignment Software Error

Siemens is recalling the epoc NXS Host blood analysis system due to a software defect that can incorrectly assign patient names to test results, potentially causing misdiagnosis and mistreatment.

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: The recall involves a medical device with a software defect that has the potential to cause patient harm through misdiagnosis and mistreatment. However, no illnesses or injuries have been reported, and the hazard is theoretical rather than documented, placing it in the High severity category.

Plain-English summary

Siemens Healthcare Diagnostics is recalling the epoc NXS Host blood analysis system (Siemens Material Number 11413475, Software Version 4.14.9), an in vitro diagnostic device used by medical professionals for blood testing. Approximately 6,738 units have been distributed nationwide and internationally.

The recall is due to a software malfunction that, under specific conditions, can incorrectly assign a patient's name to a blood test result. This error occurs only if the user fails to verify the correct patient name before accepting the result. If wrong patient information is saved with the test result, it could lead to misdiagnosis and mistreatment by clinicians who rely on the incorrect patient data.

Healthcare facilities and healthcare providers using the epoc NXS Host should contact Siemens Healthcare Diagnostics for information on correcting or replacing affected devices.

The recalled product

Product: epoc NXS Host; Siemens Material Number (SMN): 11413475 (US); Software Version Number: 4.14.9. Intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial, venous or…
Manufacturer: Siemens Healthcare Diagnostics, Inc.
Category: Medical Device — In Vitro Diagnostic / Blood Analysis
Hazard: patient-misidentification
misdiagnosis
mistreatment
Affected units: 6,738

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 (2)

Siemens Material Number: 11413475
UDI-DI: 00630414606095 Software Version Number: 4.14.9.

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 8 recalled by Siemens Healthcare Diagnostics, Inc. 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 8 products in this recall →

Same manufacturer · Siemens Healthcare Diagnostics, Inc.

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Same hazard · patient misidentification