The Recall Desk
HighFDA (Devices)·Z-0736-2025·Announced 2025-01-01

Siemens epoc Blood Analysis System Recalled for Patient Identification Software Error

Siemens is recalling epoc NXS Host blood analysis systems due to a software malfunction that can assign incorrect patient names to test results, potentially leading to misdiagnosis and mistreatment if not verified by the user.

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 FDA Class II device recall involves a real software malfunction affecting patient identification in blood testing. While no illnesses or injuries have been reported, the potential for misdiagnosis and mistreatment due to incorrect patient name assignment in a medical device critical to patient care justifies a high severity rating.

Plain-English summary

Siemens Healthcare Diagnostics is recalling the epoc NXS Host blood analysis system due to a software malfunction in version 4.14.9. The malfunction can cause the device to assign an incorrect patient name to a blood test result if the user does not verify the correct patient name during data entry or review.

This incorrect patient assignment could result in the wrong patient information being saved with the test result. Healthcare providers who rely on this data for clinical decision-making may misdiagnose or mistreat a patient based on results attributed to the wrong individual.

Approximately 670 units of the affected device have been distributed nationwide and internationally, including to Albania, Angola, Argentina, Australia, Austria, Bahrain, Bangladesh, and many other countries. The affected devices are identified by Siemens Material Number 11413498 and software version number 4.14.9.

Healthcare facilities and medical professionals currently using this device should verify that patient names are correctly matched to blood test results before relying on the results for clinical decision-making. Users should contact Siemens Healthcare Diagnostics for information about addressing this malfunction.

The recalled product

Product
epoc NXS Host; Siemens Material Number (SMN): 11413498(JP) ; 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 capi
Manufacturer
Siemens Healthcare Diagnostics, Inc.
Category
Medical Device — In Vitro Diagnostic
Hazard
  • patient-identification-error
  • misdiagnosis-risk
  • mistreatment-risk

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: 11413498
  • UDI-DI: 00630414605814
  • Software Version Number: 4.14.9.

Distribution

Distributed nationwide across the United States.

Related recalls

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