Agency classClass IIOur severity:High FDA (Devices)·Z-0737-2025·Announced 2025-01-01

Blood Analysis System Software Malfunction May Assign Incorrect Patient Names

Siemens epoc NXS Host blood analysis systems contain a software malfunction that may assign incorrect patient names to blood measurements. This could result in clinicians making treatment decisions based on the wrong patient's test results.

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 is a Class II FDA recall of a medical device with a software defect that poses a theoretical risk of patient harm through misidentification, without reported injuries. Per the severity rubric, risk-of-harm products where injury has not yet been reported are scored as High (3).

Plain-English summary

The FDA is recalling the Siemens epoc NXS Host blood analysis system (Siemens Material Number 11413506, Software Version 4.14.9) due to a software malfunction. When specific criteria are met, this malfunction can cause an incorrect patient name to be assigned to a blood measurement.

The epoc NXS Host is an in vitro diagnostic device used by trained medical professionals in laboratories and point-of-care settings to perform quantitative testing on arterial, venous, or capillary blood samples. If an incorrect patient name is assigned to a measurement and saved with the test result, clinicians may misdiagnose or mistreat patients based on results incorrectly associated with the wrong individual.

The recalled device consists of 320 units distributed nationwide and internationally, including Canada, the United Kingdom, Australia, and other countries.

The recalled product

Product: epoc NXS Host; Siemens Material Number (SMN): 11413506 (CA); 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 — Blood Analysis / Diagnostic
Hazard: software-malfunction
patient-misidentification
misdiagnosis-risk
mistreatment-risk
Affected units: 320

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 (3)

Siemens Material Number: 11413506
UDI-DI: 00630414605821
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 · software malfunction