Siemens Healthcare Diagnostics, Inc.: Medical Device Recall in 2025 - (Recall #: Z-0735-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: November 22, 2024

Date Posted: January 1, 2025

Recall Number: Z-0735-2025

Event ID: 95809

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.

Status: Ongoing

Product Quantity: 3,011 units

Code Information:

Siemens Material Number: 11413497; UDI-DI: 00630414605760 Software Version Number: 4.14.9.

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated