The Recall Desk
HighFDA (Devices)·Z-0740-2025·Announced 2025-01-01

Siemens Blood Analysis Device Recalled Over Patient Name Mix-up Software Defect

Siemens is recalling the epoc NXS blood analysis system due to a software flaw that can assign incorrect patient names to test results, risking misdiagnosis or mistreatment if the operator doesn't verify the patient name.

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 is an FDA Class II medical device recall involving a software malfunction that could result in patient misidentification and subsequent misdiagnosis or mistreatment. However, no illnesses, injuries, or deaths have been reported, and the hazard is theoretical rather than actual, placing it in the High category per the rubric criterion for high-risk products without reported harm.

Plain-English summary

Siemens Healthcare Diagnostics, Inc. is recalling the epoc NXS Host blood analysis system due to a software malfunction in version 4.14.9. The flaw can occur when specific criteria are met and may cause the device to incorrectly assign a patient's name to a blood measurement result.

Medical professionals using this device need to know that if they do not verify the correct patient name, the wrong patient information could be saved with the test result. This could lead to misdiagnosis or mistreatment by a clinician who relies on the incorrect patient data.

The recall affects 23 units with material number 11413583 (SMN) and software version 4.14.9. The device has been distributed nationwide and internationally to medical laboratories and point-of-care testing facilities.

Users should verify patient identification information carefully when using this device and contact Siemens Healthcare Diagnostics for instructions on obtaining a software update or replacement.

The recalled product

Product
epoc NXS Host; Siemens Material Number (SMN): 11413583(CN, KR) ; 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 — Hematology / Blood Analysis
Hazard
  • patient-name-mismatch
  • misdiagnosis-risk
  • software-malfunction

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: 11413583
  • UDI-DI: 00630414612447
  • Software Version Number: 4.14.9.

Distribution

Distributed nationwide across the United States.

Related recalls

Same category