epoc Host 2 as follows: Product SMN epoc NXS Host, US 11413475 epoc NXS Hos...
FDA Device Recall #Z-1215-2023 — Class II — December 12, 2022
Recall Summary
| Recall Number | Z-1215-2023 |
| Classification | Class II — Moderate risk |
| Date Initiated | December 12, 2022 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Siemens Healthcare Diagnostics Inc |
| Location | Norwood, MA |
| Product Type | Devices |
| Quantity | 4,369 units |
Product Description
epoc Host 2 as follows: Product SMN epoc NXS Host, US 11413475 epoc NXS Host, EU 11413497 epoc NXS Host, Japan 11413498 epoc NXS Host, Canada 11413506 epoc NXS Host, ROW 11413518 epoc NXS Host, China-Korea 11413583
Reason for Recall
pO2 High Recovery in Quality Control When Adjusted for Barometric Pressure
Distribution Pattern
Nationwide Foreign: Algeria Argentina Australia Austria Bahrain Belarus Belgium Bolivia Brazil Cambodia Canada Chile China Colombia Croatia Czech Republic Denmark Ecuador Egypt Estonia Finland France Fren.Polynesia Georgia Germany Greece Guadeloupe Hong Kong Hungary Iceland India Indonesia Iran Ireland Israel Italy Japan Jordan Kazakhstan Kenya Kuwait Laos Latvia Lithuania Luxembourg Malaysia Mali Martinique Mexico Myanmar Netherlands New Caledonia New Zealand Norway Papua Nw Guinea Peru Philippines Poland Portugal Qatar Republic Korea Reunion Romania Russian Fed. San Marino Singapore Slovakia Slovenia Solomon Islands South Africa Spain Sweden Switzerland Taiwan Thailand Tunisia Turkey U.A.E. Ukraine United Kingdom Uruguay Vietnam
Lot / Code Information
Host Software Version /Sensor Configuration: 4.10.6/41.1 Product Description Siemens Material Number (SMN) (UDI-DI) epoc NXS Host, US 11413475 00630414606095; epoc NXS Host, EU 11413497 00630414605760; epoc NXS Host, Japan 11413498 00630414605814; epoc NXS Host, Canada 11413506 00630414605821; epoc NXS Host, ROW 11413518 00630414605678; epoc NXS Host, China-Korea 11413583 00630414612447 .
Other Recalls from Siemens Healthcare Diagnostics Inc
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2005-2026 | Class II | epoc BGEM BUN Test Card (25 pk) for the epoc Bl... | Apr 2, 2026 |
| Z-2272-2025 | Class II | epoc BGEM BUN Test Card [25pk]. Material Number... | Jul 7, 2025 |
| Z-2230-2025 | Class II | RAPIDPoint 500 Systems Wash/Waste Cartridge (4 ... | Jun 26, 2025 |
| Z-1673-2025 | Class II | Stratus CS Acute Care cTNI TestPak.IVD test for... | Mar 31, 2025 |
| Z-1684-2025 | Class II | epoc BGEM BUN Test Card (25 pk) for the epoc Bl... | Mar 19, 2025 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.