Reported Mar 15, 2023 · Ongoing

epoc Host 2 as follows: Product SMN epoc NXS Host, US 11413475 epoc NXS Host, EU 11413497 epoc NXS Host, Japan 11413498…

Siemens Healthcare Diagnostics Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Siemens Healthcare Diagnostics Inc · 2 Edgewater Dr · Norwood, MA · 02062-4637

Is this the product you have?

  • 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
Lot codes and dates

6 of 6 products

Products covered by this recall
#BarcodesProduct as published
10063041460609510.6/41.1 Product Description Siemens Material Number (SMN) (UDI-DI) epoc NXS Host, US 11413475 00630414606095
200630414605760epoc NXS Host, EU 11413497 00630414605760
300630414605814epoc NXS Host, Japan 11413498 00630414605814
400630414605821epoc NXS Host, Canada 11413506 00630414605821
500630414605678epoc NXS Host, ROW 11413518 00630414605678
600630414612447epoc NXS Host, China-Korea 11413583 00630414612447 .
Amount recalled
4,369 units

This recall covers 2 products

The agency filed one notice per product. You are reading one of them; the other one is below.

Where it was sold

  • Nationwide
  • GA

Why it was recalled

pO2 High Recovery in Quality Control When Adjusted for Barometric Pressure

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 6:59 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.