Home / Recalls / Siemens Healthcare Diagnostics Inc / Z-1215-2023

Z-1215-2023 Class II Ongoing

Recalled by Siemens Healthcare Diagnostics Inc — Norwood, MA

FDA device recall Z-1215-2023 was initiated by Siemens Healthcare Diagnostics Inc on Dec 12, 2022 and is designated Class II. Reason for recall: pO2 High Recovery in Quality Control When Adjusted for Barometric Pressure The recall status is ongoing. Affected quantity: 4,369 units.

Recall Details

Product Type: Devices
Report Date: Mar 15, 2023
Initiation Date: Dec 12, 2022
Voluntary/Mandated: Voluntary: Firm initiated
Product 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

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 .

Source

Dataset: openFDA device recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for Z-1215-2023
openFDA file date: Oct 21, 2026
Loaded by RegDataLab: Oct 23, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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