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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Diagnostic Equipment

Siemens Healthcare Diagnostics Inc: epoc NXS Host Blood Analysis System Recalled for Erroneous Test Results

Agency Publication Date: December 21, 2023
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Summary

Siemens Healthcare Diagnostics Inc. is recalling 10,183 epoc NXS Host Blood Analysis Systems due to a software defect that can cause incorrect patient test results to be printed or saved. While results displayed on the screen during testing are accurate, the system may include data from previous patients or quality control tests when printing or transferring records. This issue affects devices with software versions 4.9.4 through 4.11.11, which are used for critical blood analysis in clinical settings. Consumers should contact Siemens or their healthcare provider for instructions on managing affected devices.

Risk

A software error can cause unselected data from prior tests to be merged into a current patient's report, potentially leading to a failure to diagnose life-threatening conditions like high potassium (hyperkalemia) or causing inappropriate treatment for high blood sugar (hyperglycemia) based on incorrect glucose readings.

What You Should Do

  1. Identify if your device is affected by checking the model and Siemens Material Number (SMN) on your epoc NXS Host: 11413497 (EU), 11413475 (US), 11413506 (CA), 11413517 (MX), 11413518 (ROW), 11413498 (JP), 11413583 (CN, KR), or 11413879 (IN).
  2. Verify the software version currently installed on your device; this recall specifically impacts versions 4.9.4 through 4.11.11.
  3. Check the device for the following Unique Device Identifier (UDI) codes: 00630414605760, 00630414606095, 00630414605821, 00630414605838, 00630414605678, 00630414605814, 00630414612447, or 00630414631028.
  4. Be aware that the 'Delete Blood Tests' feature, when enabled, triggers this specific software problem during printing or data transfer.
  5. Contact your healthcare provider or Siemens Healthcare Diagnostics Inc. at 2 Edgewater Dr, Norwood, MA 02062 for technical support, software update instructions, and guidance on verifying patient records.
  6. For further information or to report additional issues, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Software-related corrective action

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: epoc NXS Host Blood Analysis System (US)
Model / REF:
11413475
UPC Codes:
00630414606095
Lot Numbers:
All serial numbers
Product: epoc NXS Host Blood Analysis System (EU)
Model / REF:
11413497
UPC Codes:
00630414605760
Lot Numbers:
All serial numbers
Product: epoc NXS Host Blood Analysis System (CA)
Model / REF:
11413506
UPC Codes:
00630414605821
Lot Numbers:
All serial numbers
Product: epoc NXS Host Blood Analysis System (MX)
Model / REF:
11413517
UPC Codes:
00630414605838
Lot Numbers:
All serial numbers
Product: epoc NXS Host Blood Analysis System (ROW)
Model / REF:
11413518
UPC Codes:
00630414605678
Lot Numbers:
All serial numbers
Product: epoc NXS Host Blood Analysis System (JP)
Model / REF:
11413498
UPC Codes:
00630414605814
Lot Numbers:
All serial numbers
Product: epoc NXS Host Blood Analysis System (CN, KR)
Model / REF:
11413583
UPC Codes:
00630414612447
Lot Numbers:
All serial numbers
Product: epoc NXS Host Blood Analysis System (IN)
Model / REF:
11413879
UPC Codes:
00630414631028
Lot Numbers:
All serial numbers

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93388
Status: Active
Manufacturer: Siemens Healthcare Diagnostics Inc
Sold By: Siemens Healthcare Diagnostics Inc
Manufactured In: United States
Units Affected: 10,183 devices
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.