Use caution Medical device recall · FDA · Published November 22, 2024

Siemens epoc NXS Host Software Recall: Risk of Wrong Patient Name in Blood Tests

Siemens Healthcare recalls epoc NXS Host software version 4.14.9 due to potential misassignment of patient names in blood tests, risking misdiagnosis. Affected units may need verification steps.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0736-2025Medical device Siemens Healthcare ›

Use caution until it’s fixed

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.

Take action

Contact the company

Recalling firmSiemens Healthcare Diagnostics, Inc.333 Coney St · East Walpole, MA 02032-1516

✎ GovInfoNow plain-language explainer

Siemens Healthcare is recalling its epoc NXS Host blood analysis system software version 4.14.9 because a software glitch could assign the wrong patient name to blood test results if not properly verified. This could lead to incorrect patient treatment if the wrong name is saved with test results. Read more at govinfonow.com/recall/53419-siemens-epoc-nxs-host-software-recall-risk-of-wrong-patient.

Source Summary by GovInfoNow · govinfonow.com/recall/53419-siemens-epoc-nxs-host-software-recall-risk-of-wrong-patient · Updated August 18, 2026 · FDA enforcement record: FDA #Z-0736-2025

Cite this page

“Siemens epoc NXS Host Software Recall: Risk of Wrong Patient Name in Blood Tests.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/53419-siemens-epoc-nxs-host-software-recall-risk-of-wrong-patient. Based on FDA recall #Z-0736-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0736-2025%22&limit=1).

The FDA announced on November 22, 2024, that Siemens Healthcare Diagnostics is recalling the epoc NXS Host blood analysis system due to a software malfunction that may assign incorrect patient names to test results. This error poses a risk of misdiagnosis and mistreatment by clinicians. Owners should contact Siemens for remedy details.

How to tell if you have it

Brand: Siemens Healthcare
Product: epoc NXS Host
Siemens Material Number (SMN): 11413498(JP)
Software Version Number: 4.14.9
UDI-DI: 00630414605814

The hazard

According to the FDA, a software malfunction can result in the incorrect patient name being assigned to a blood measurement if the user does not verify the correct name. This 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.

Context

GovInfoNow's records show Siemens Healthcare Diagnostics, Inc. has had 150 other recalls on record since June 7, 2017. Other recent recalls of similar products include Siemens Atellica CH RCRP Test (August 17, 2026), Beckman Coulter Emit 2000 Quinidine Assay Recall (July 13, 2026), and Siemens Atellica CH Urine Albumin Recall (July 6, 2026). Other recent recalls of similar products include Nova Biomedical StatStrip Glucose Meter System Recall (July 29, 2026) and GE Healthcare Core Services Hub V8 Recall (July 31, 2026).

How to tell if you have this one

Check for Siemens Material Number (SMN) 11413498(JP) and software version 4.14.9 on the device. The device is intended for use by trained medical professionals in labs or at point-of-care settings.

Brand
Siemens Healthcare
Category
Medical device

FDA recall event · 8 products

All 8 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Ongoing
Distribution
Nationwide Foreign: Albania Angola Argentina Australia Austria Bahrain Bangladesh Belarus Belgium Bolivia Bosnia and Herzegovina Brazil Cambodia Canada Chile China Colombia Croatia Czech Republic Denmark Ecuador Egypt Estonia Finland France Germany Ghana Greece Guadeloupe Hong Kong Hungary Iceland India Indonesia Iraq Ireland Israel Italy Japan Jordan Kazakhstan Kuwait Latvia Lithuania Luxembourg Macau Madagascar Malaysia Mexico Monaco Mongolia Morocco Myanmar Netherlands New Caledonia New Zealand Norway Paraguay Peru Philippines Poland Portugal Republic Korea Romania Russian Federation Saudi Arabia Singapore Slovakia Slovenia South Africa Spain Sri Lanka Swaziland Sweden Switzerland Thailand Tunisia Turkey Ukraine United Arab Emirates United Kingdom Great Britain Uruguay Vietnam

Recall number	Product, codes & lots	Quantity
Z-0734-2025	epoc NXS Host; Siemens Material Number (SMN): 11413475 (US); 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 capillary whole blood in the laboratory or at the point of care.; Siemens Material Number: 11413475; UDI-DI: 00630414606095 Software Version Number: 4.14.9.	6,738 units
Z-0735-2025	epoc NXS Host; Siemens Material Number (SMN): 11413497 (EU); 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 capillary whole blood in the laboratory or at the point of care.; Siemens Material Number: 11413497; UDI-DI: 00630414605760 Software Version Number: 4.14.9.	3,011 units
Z-0736-2025	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 capillary whole blood in the laboratory or at the point of care.; Siemens Material Number: 11413498; UDI-DI: 00630414605814; Software Version Number: 4.14.9.	670 units
Z-0737-2025	epoc NXS Host; Siemens Material Number (SMN): 11413506 (CA); 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 capillary whole blood in the laboratory or at the point of care.; Siemens Material Number: 11413506; UDI-DI: 00630414605821; Software Version Number: 4.14.9.	320 units
Z-0738-2025	epoc NXS Host; Siemens Material Number (SMN): 11413517(MX) ; 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 capillary whole blood in the laboratory or at the point of care.; Siemens Material Number: 11413517; UDI-DI: 00630414605838; Software Version Number: 4.14.9.	1 unit
Z-0739-2025	epoc NXS Host; Siemens Material Number (SMN): 11413518 (ROW) ; 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 capillary whole blood in the laboratory or at the point of care.; Siemens Material Number: 11413518; UDI-DI: 00630414605678; Software Version Number: 4.14.9.	2240 units
Z-0740-2025	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 capillary whole blood in the laboratory or at the point of care.; Siemens Material Number: 11413583; UDI-DI: 00630414612447; Software Version Number: 4.14.9.	23 units
Z-0741-2025	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 capillary whole blood in the laboratory or at the point of care.; Siemens Material Number: 11413879; UDI-DI: 00630414631028; Software Version Number: 4.14.9.	276 units

Based on the official FDA remedy

What to do — step by step

Verify Patient Name
Ensure the correct patient name is entered and verified before running blood tests to prevent misassignment.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA distribution: “Nationwide Foreign: Albania Angola Argentina Australia Austria Bahrain Bangladesh Belarus Belgium Bolivia Bosnia and Herzegovina Brazil Cambodia Canada Chile China Colombia Croatia Czech Republic Denmark Ecuador Egypt Estonia Finland…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA published this recall 40 days after the firm started it.

Nov 22, 2024Firm started the recall
Dec 20, 2024FDA classified it Class II
Jan 1, 2025Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/53419-siemens-epoc-nxs-host-software-recall-risk-of-wrong-patient">Siemens epoc NXS Host Software Recall: Risk of Wrong Patient Name in Blood Tests (GovInfoNow)</a>

Where this comes from

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.

Official source: FDA Recall #Z-0736-2025 (November 22, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0736-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.