Lower risk Medical device recall · FDA · Published December 12, 2022

Siemens Healthcare Diagnostics Epoc Host 2 Recall: P O2 High Recovery Risk in QC

Siemens Healthcare recalls Epoc Host 2 devices with specific model numbers due to potential high oxygen recovery during quality control when adjusted for barometric pressure. Affected units include Canada, China, Japan, and refurbished models.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1214-2023Medical device Siemens Healthcare ›

Lower-risk recall

pO2 High Recovery in Quality Control When Adjusted for Barometric Pressure

Take action

Contact the company

Recalling firmSiemens Healthcare Diagnostics Inc2 Edgewater Dr · Norwood, MA 02062-4637

✎ GovInfoNow plain-language explainer

Siemens Healthcare is recalling Epoc Host 2 devices with specific model numbers sold in Canada, China, Japan, and refurbished versions. The issue involves a potential high oxygen recovery reading during quality control testing when adjusted for barometric pressure, which could lead to inaccurate results. Read more at govinfonow.com/recall/59169-siemens-healthcare-diagnostics-epoc-host-2-recall-p-o2-high.

Source Summary by GovInfoNow · govinfonow.com/recall/59169-siemens-healthcare-diagnostics-epoc-host-2-recall-p-o2-high · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1214-2023

Cite this page

“Siemens Healthcare Diagnostics Epoc Host 2 Recall: P O2 High Recovery Risk in QC.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/59169-siemens-healthcare-diagnostics-epoc-host-2-recall-p-o2-high. Based on FDA recall #Z-1214-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1214-2023%22&limit=1).

Siemens Healthcare Diagnostics Inc. is recalling epoc Host 2 devices due to pO2 high recovery in quality control when adjusted for barometric pressure, according to the FDA. The agency announced the voluntary Class II recall on Dec. 12, 2022.

How to tell if you have it

Brand: Siemens Healthcare
Product: epoc Host 2
SMN 10736387, UDI-DI 00809708052898
SMN 10736388, UDI-DI 00809708069117
SMN 10736389, UDI-DI 00809708097219
SMN 10736390, UDI-DI 00809708075576
SMN 10736393, UDI-DI 00809708053901
SMN 10736394, UDI-DI 00809708069124
SMN 10736395, UDI-DI 00809708075583
SMN 10736433, UDI-DI 00809708097226
SMN 11413524, UDI-DI 00630414606460
SMN 11413528, UDI-DI 00630414606378
SMN 11413541, UDI-DI 00630414608617
SMN 11413542, UDI-DI 00630414608624
SMN 11413543, UDI-DI 00630414608532
SMN 11413601, UDI-DI 00630414615004
SMN 11413602, UDI-DI 00630414614885
SMN 1413603, UDI-DI 00630414614762
SMN 11413604, UDI-DI 00630414614892
Host Software Version /Sensor Configuration: 3.37.3/41.1

The hazard

The recall addresses pO2 high recovery in quality control when adjusted for barometric pressure, according to the FDA.

Context

GovInfoNow's records show Siemens Healthcare Diagnostics, Inc. has 150 other recalls on record since June 7, 2017. Other recent recalls of similar products include Siemens Atellica CH RCRP Test May Give False High Results (Aug. 17, 2026), Siemens Healthcare Syva EMIT 2000 Quinidine Assay Recall (July 13, 2026), and Siemens Atellica CH Urine Albumin Recall (July 6, 2026). Other recent recalls of similar products include Philips Brilliance CT 64 Medical Scanner Recall (Aug. 7, 2026) and Philips Allura Xper FD10C Medical System Recall (Dec. 15, 2025).

How to tell if you have this one

Check for model numbers like 10736387 (Canada), 10736388 (China), or 10736390 (Japan) on the device label. Refurbished models with the same model numbers are also included in the recall.

Brand
Siemens Healthcare
Category
Medical device

FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Ongoing
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

Recall number	Product, codes & lots	Quantity
Z-1214-2023	epoc Host 2 as follows: Product SMN epoc Host 10736387 epoc Host 2, Canada 10736388 epoc Host 2, China 10736389 epoc Host 2, Japan 10736390 epoc Host 2, Refurbished 10736393 epoc Host 2, Canada, Refurbished 10736394 epoc Host 2, Japanese, Refurbished 10736395 epoc Host 2, Chinese, Refurbished 10736433 epoc Host 2, US (MC55X) 11413524 epoc Host 2, ROW (MC55X) 11413528 epoc Host 2, India (MC55X) 11413541 epoc Host 2, China (MC55X) 11413542 epoc Host 2, Japan (MC55X) 11413543 epoc Host 2 (MC55X) - US - Refurbished 11413601 "epoc Host 2 (MC55X) - ROW -Refurbished" 11413602 epoc Host 2 (MC55X) - India - Refurbished 11413603 epoc Host 2 (MC55X) - Japan - Refurbished 11413604; Host Software Version /Sensor Configuration: 3.37.3/41.1 Product Description Siemens Material Number (SMN) Unique Device Identification (UDI-DI) epoc Host 2 10736387 00809708052898; epoc Host 2, Canada 10736388 00809708069117; epoc Host 2, China 10736389 00809708097219; epoc Host 2, Japan 10736390 00809708075576; epoc Host 2, Refurbished 10736393 00809708053901; epoc Host 2, Canada, Refurbished 10736394 00809708069124; epoc Host 2, Japanese, Refurbished 10736395 00809708075583; epoc Host 2, Chinese, Refurbished 10736433 00809708097226; epoc Host 2, US (MC55X) 11413524 00630414606460; epoc Host 2, ROW (MC55X) 11413528 00630414606378; epoc Host 2, India (MC55X) 11413541 00630414608617; epoc Host 2, China (MC55X) 11413542 00630414608624; epoc Host 2, Japan (MC55X) 11413543 00630414608532; epoc Host 2 (MC55X) - US - Refurbished 11413601 00630414615004; "epoc Host 2 (MC55X) - ROW - Refurbished" 11413602 00630414614885; epoc Host 2 (MC55X) - India - Refurbished 1413603 00630414614762; epoc Host 2 (MC55X) - Japan - Refurbished 11413604 00630414614892.	22,156 units
Z-1215-2023	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; 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 .	4,369 units

Based on the official FDA remedy

What to do — step by step

Check Device Model
Look for model numbers on the device label, such as 10736387 for Canada or 10736388 for China.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA 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…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA published this recall 3 months after the firm started it.

Dec 12, 2022Firm started the recall
Mar 3, 2023FDA classified it Class II
Mar 15, 2023Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/59169-siemens-healthcare-diagnostics-epoc-host-2-recall-p-o2-high">Siemens Healthcare Diagnostics Epoc Host 2 Recall: P O2 High Recovery Risk in QC (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-1214-2023 (December 12, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1214-2023 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.