epoc Host 2 Diagnostic Analyzers Recalled for Oxygen Measurement Inaccuracy
Siemens Healthcare Diagnostics is recalling 4,369 epoc Host 2 blood gas analyzers due to elevated oxygen measurements in quality control testing when adjusted for barometric pressure. No illnesses reported.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall with no reported illnesses, injuries, or deaths. The hazard is measurement inaccuracy in a diagnostic device's quality control context, representing a quality concern rather than documented patient harm.
Plain-English summary
Siemens Healthcare Diagnostics Inc. is recalling epoc Host 2 blood gas analyzers (4,369 units) with software version 4.10.6 and sensor configuration 41.1 due to a measurement accuracy issue. The recall addresses elevated oxygen partial pressure (pO2) readings detected during quality control testing when adjusted for barometric pressure.
The recalled devices were distributed nationwide in the United States and internationally to countries including Canada, the United Kingdom, Japan, Australia, and numerous other nations.
Healthcare facilities using affected epoc Host 2 analyzers should contact Siemens Healthcare Diagnostics for recall details and information about available remediation options.
The recalled product
- 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
- Manufacturer
- Siemens Healthcare Diagnostics Inc
- Affected units
- 4,369
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (7)
- US 11413475 00630414606095
- epoc NXS Host
- EU 11413497 00630414605760
- Japan 11413498 00630414605814
- Canada 11413506 00630414605821
- ROW 11413518 00630414605678
- China-Korea 11413583 00630414612447 .
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Siemens Healthcare Diagnostics Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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