Agency classClass IIOur severity:High FDA (Devices)·Z-0741-2025·Announced 2025-01-01

Siemens epoc blood analyzer software assigns incorrect patient names

Siemens epoc NXS blood analysis system has a software defect that can incorrectly assign patient names to blood test results, potentially causing misdiagnosis or 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: This is a FDA Class II recall involving a medical device with potential for patient harm (misdiagnosis and mistreatment). However, no illnesses or injuries have been reported, and the hazard is theoretical. Per the rubric, risk-of-harm products where injury has not yet been reported score as High (3).

Plain-English summary

Siemens Healthcare Diagnostics, Inc. is recalling the epoc NXS Host blood analysis system. The device is intended for use by trained medical professionals as an in vitro diagnostic device for quantitative testing of blood samples in laboratory or point-of-care settings.

The recall is due to a software malfunction in version 4.14.9 that can result in incorrect patient names being assigned to blood test results when specific criteria are met. If users do not ensure verification of the correct patient name, the wrong patient information may be saved with the test result.

Approximately 276 units were distributed nationwide and internationally. The software malfunction has the potential to impact patient safety via misdiagnosis and/or mistreatment by clinicians if the wrong patient information is associated with a test result.

The recalled product

Product: epoc NXS Host; Siemens Material Number (SMN): 11413879(IN) ; 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 System
Hazard: software-malfunction
patient-misidentification
misdiagnosis-risk
mistreatment-risk
Affected units: 276

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: 11413879
UDI-DI: 00630414631028
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 →

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Same hazard · software malfunction