Siemens Healthcare recalls epoc NXS Host blood analysis systems with software version 4.14.9 due to potential misassignment of patient names, risking incorrect diagnoses and treatment. Affected units have specific material numbers and were sold in Europe.
Siemens Healthcare Diagnostics is recalling their epoc Blood Analysis System because of a software malfunction that occurs when specific criteria are met that can result in the incorrect patient name being assigned to a blood measurement by the device if the user of the device does not ensure verification of the correct patient name. The software malfunction has the potential to impact patient safety via misdiagnosis and/or mistreatment by a clinician if the wrong patient information is saved with the test result from the subject device.
Siemens Healthcare is recalling its epoc NXS Host blood analysis systems because a software issue can cause the device to assign the wrong patient name to blood test results. This could lead to misdiagnosis or incorrect treatment if the wrong patient information is saved with the test results.
The software malfunction can cause the device to incorrectly assign a patient's name to blood test results if the user doesn't verify the correct name. This risk exists when specific criteria are met, potentially leading to misdiagnosis or mistreatment by clinicians if the wrong patient information is linked to the test results.
Medical professionals using the epoc NXS Host for blood testing in labs or clinics are most at risk. The recall applies to specific units sold in Europe with the Siemens Material Number 11413497 and software version 4.14.9.
Check for the Siemens Material Number 11413497 (EU) and software version 4.14.9 on the device. The epoc NXS Host is used for blood testing in labs or at point-of-care settings by trained medical professionals.
Check the device for software version 4.14.9 and Siemens Material Number 11413497 (EU).
The recall is due to a software malfunction that can cause the device to assign the wrong patient name to blood test results if the user doesn't verify the correct name.
The device could misdiagnose patients or lead to incorrect treatment if the wrong patient information is saved with the test results.
Check for the Siemens Material Number 11413497 (EU) and software version 4.14.9 on the device.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0735-2025 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-0735-2025 from Siemens Healthcare. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
