FDA Medical devices recall ·
epoc NXS Host recall
- Recall number
- Z-0735-2025
- Date
- (initiated November 22, 2024)
- Company / brand
- Siemens Healthcare Diagnostics, Inc.
333 Coney St, East Walpole, MA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 3,011 units
- Hazard tags
- Software
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
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.
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Siemens Material Number: 11413497; UDI-DI: 00630414605760 Software Version Number: 4.14.9.
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
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0735-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.