# FDA recall Z-1215-2023

> **Siemens Healthcare Diagnostics Inc** · Class II · device recall initiated 2022-12-12.

## Product

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

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

## Key facts

- **Recall number:** Z-1215-2023
- **Recalling firm:** Siemens Healthcare Diagnostics Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-12-12
- **Report date:** 2023-03-15

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Norwood, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1215-2023

## Citation

> AI Analytics. FDA recall Z-1215-2023. Retrieved 2026-07-19 from https://api.ai-analytics.org/recall/Z-1215-2023. Source: US FDA. Licensed CC0.

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