Siemens Healthcare recalls epoc NXS Host software version 4.14.9 due to potential misassignment of patient names in blood tests, risking misdiagnosis and patient safety. Affected units have specific material numbers.
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 system software version 4.14.9 because a software glitch can assign the wrong patient name to blood test results if not properly verified. This could lead to incorrect diagnoses or treatments if the wrong patient information is saved with test results.
The software malfunction can assign the incorrect patient name to blood test results when specific criteria are met. If the user does not verify the correct patient name before finalizing the test, the device may save the wrong patient information with the test result, potentially causing misdiagnosis or mistreatment.
Trained medical professionals using the epoc NXS Host for blood testing at labs or clinics. Patients receiving blood tests with this device are at risk if the wrong patient name is linked to their results.
Check for Siemens Material Number (SMN) 11413583 (for China and Korea) and software version 4.14.9 on the device. The device is intended for use by trained medical professionals in laboratories or at the point of care.
Ensure the correct patient name is confirmed before the device saves the test result to prevent misassignment.
The device is safe to use if the user verifies the correct patient name before finalizing the test. Without verification, there is a risk of misassignment.
Software version 4.14.9 is affected. The recall applies to devices with Siemens Material Number (SMN) 11413583 (for China and Korea).
No, but you must verify the patient name before finalizing the test to avoid misassignment. The recall does not require immediate discontinuation.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0740-2025 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-0740-2025 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.
