CLASS II ONGOING Device recall · Reported 1 Jan 2025 · FDA Enforcement Report
epoc NXS Host recalled by Siemens Healthcare Diagnostics
Siemens Healthcare Diagnostics is recalling epoc NXS Host, distributed nationwide in the US. The recall was initiated on 22 Nov 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0736-2025
- FDA event ID
- 95809
- Recalling firm
- Siemens Healthcare Diagnostics, East Walpole, MA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 22 Nov 2024
- FDA classified
- 20 Dec 2024
- Reported
- 1 Jan 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Test Kits & Diagnostics
Timeline
| 22 Nov 2024 | Recall initiated by company | |
| 20 Dec 2024 | Classified by FDA | +28 days |
| 1 Jan 2025 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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.
Where it was distributed
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
Questions about this recall
Is epoc NXS Host recalled?
Yes. Siemens Healthcare Diagnostics recalled epoc NXS Host on 22 Nov 2024. The recall is Class II and its status is Ongoing. Recall number Z-0736-2025.
Why was it recalled?
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.
Which lots are affected?
Siemens Material Number: 11413498; UDI-DI: 00630414605814; Software Version Number: 4.14.9.
Where was it sold?
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
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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