epoc NXS Host 11413475Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00630414606095), received between Oct 26, 2023 and Mar 7, 2024 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (5 reports).

2 FDA recall records name this device's identifier, 2 still open.

17 other recalls cover devices cleared under the same FDA submission (K200107); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Nov 22, 2024Class IIOpen, Classified

   Siemens Healthcare Diagnostics is recalling their epoc Blood Analysis System because of a software malfunction that occurs when specific criteria are met that can result in the incorrect patient name being assigned to a blood measurement by the device if the user of the device does not ensure verification of the correct patient name. The software malfunction has the potential to impact patient safety via misdiagnosis and/or mistreatment by a clinician if the wrong patient information is saved with the test result from the subject device.

   Z-0734-2025 · Root cause: Software design · Recall details · FDA record ↗

2. Dec 12, 2022Class IIOpen, Classified

   pO2 High Recovery in Quality Control When Adjusted for Barometric Pressure

   Z-1215-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 7, 2024Use of Device Problem; Use of Device Problem

  THE CUSTOMER STATED THAT AN OPERATOR LOGGED INTO THEIR EPOC INSTRUMENT TO RUN A TEST ON (B)(6) 2024 AT 06:50. PATIENT 1 WAS SCANNED, BUT THE USER RECEIVED AN ERROR CODE AND WAS UNABLE TO RUN THE TEST AT THAT TIME. ANOTHER USER THEN USED THE SAME EPOC INSTRUMENT TO RUN A TEST AT 12:55 ON PATIENT 2, AND THE ORIGINAL PID FOR PATIENT 1 WAS STILL PROGRAMMED INTO THE HOST AT THE TIME OF TESTING SO THE RESULTS FOR PATIENT 2 WERE SENT TO THE CHART OF PATIENT 1. THE RESULTS WERE QUESTIONED BY THE PHYSICIAN AND BLOOD FOR PATIENT 2 WAS NEEDED TO BE RECOLLECTED FOR RETESTING. THE VENTILATOR SETTINGS FOR PATIENT 1 WERE CHANGED DUE TO THE INCORRECT RESULTS AND WERE CHANGED BACK AFTER RETESTING A 15:47. THERE IS NO REPORT OF HARM DUE TO THE CHANGE IN TREATMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18861413 ↗
• MalfunctionNov 22, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER ALLEGED THAT WHEN RUNNING A TEST FOR A 78 YEAR OLD FEMALE, THE RESULTS WERE INCORRECTLY APPLIED TO THE PATIENT ID FOR AN 83 YEAR OLD MALE. THE CUSTOMER STATED THAT THE TEST RUN PRIOR TO THIS MIX UP WAS FOR THE 83 YEAR OLD MALE. THE ERROR WAS NOTICED IMMEDIATELY AND THERE WAS NO CHANGE TO PATIENT TREATMENT OR DIAGNOSIS. THE TEST WAS CORRECTLY RERUN FOR THE 78 YEAR OLD FEMALE. THERE IS NO REPORT OF INJURY DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18190853 ↗
• MalfunctionOct 26, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  CUSTOMER STATED THAT WHEN PULLING RESULTS ON THEIR NXS HOST HISTORY PAGE FOR A PATIENT TEST WHERE ONLY CREATININE AND EGFR (ESTIMATED GLOMERULAR FILTRATION RATE) WERE RUN, RESULTS FOR OTHER ANALYTES THAT WERE NOT REQUESTED WERE ALSO PRESENTED. THESE RESULTS ARE ALSO SENT TO THEIR DATA MANAGER. CUSTOMER STATED THAT WHILE THE RESULTS WERE POSTED TO THE PATIENT'S CHART, THE PATIENT WAS NOT TREATED BASED ON THE RESULTS THAT WERE INAPPROPRIATELY POSTED. THERE IS NO REPORT OF INJURY DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18015677 ↗
• MalfunctionOct 26, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER ALLEGED THAT THEIR DATA MANAGER PRESENTED ALL RESULTS FOR THE ENTIRE TEST PANEL, AND NOT JUST THE ONES THEY SELECTED WHEN RUNNING THEIR EPOC INSTRUMENT. THE CUSTOMER LATER REPORTED THAT THEIR INSTRUMENT WAS OPERATING AS INTENDED AFTER UPDATING THE CONFIGURATION OF THEIR DATA MANAGER. AT THAT TIME, THIS WAS BELIEVED TO BE AN ISSUE WITH THE DATA MANAGER. ON (B)(6), DURING THE INVESTIGATION OF ANOTHER COMPLAINT, A SOFTWARE ISSUE WAS FOUND. A REVIEW OF THE INFORMATION PROVIDED BY THIS CUSTOMER DETERMINED THAT THIS COMPLAINT WAS IN SCOPE, AND IT WAS THEREFORE RE-ESCALATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18015596 ↗
• MalfunctionOct 26, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER ALLEGED THAT THEIR DATA MANAGER PRESENTED ALL RESULTS FOR THE ENTIRE TEST PANEL, AND NOT JUST THE ONES THEY SELECTED WHEN RUNNING THEIR EPOC INSTRUMENT. THE CUSTOMER LATER REPORTED THAT THEIR INSTRUMENT WAS OPERATING AS INTENDED AFTER UPDATING THE CONFIGURATION OF THEIR DATA MANAGER. AT THAT TIME, THIS WAS BELIEVED TO BE AN ISSUE WITH THE DATA MANAGER. ON (B)(6), DURING THE INVESTIGATION OF ANOTHER COMPLAINT, A SOFTWARE ISSUE WAS FOUND. A REVIEW OF THE INFORMATION PROVIDED BY THIS CUSTOMER DETERMINED THAT THIS COMPLAINT WAS IN SCOPE, AND IT WAS THEREFORE RE-ESCALATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18014747 ↗
• MalfunctionOct 26, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  CUSTOMER STATED THAT WHEN PULLING RESULTS ON THEIR NXS HOST HISTORY PAGE FOR A PATIENT TEST WHERE ONLY CREATININE AND EGFR (ESTIMATED GLOMERULAR FILTRATION RATE) WERE RUN, RESULTS FOR OTHER ANALYTES THAT WERE NOT REQUESTED WERE ALSO PRESENTED. THESE RESULTS ARE ALSO SENT TO THEIR DATA MANAGER. CUSTOMER STATED THAT WHILE THE RESULTS WERE POSTED TO THE PATIENT'S CHART, THE PATIENT WAS NOT TREATED BASED ON THE RESULTS THAT WERE INAPPROPRIATELY POSTED. THERE IS NO REPORT OF INJURY DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18012534 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K200107. One submission often covers many models, so check the product and lot details in each record.

• Z-2005-2026 · Apr 2, 2026 · Open, Classified
  epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System; Siemens Material Number (SMN): 10736515;
• Z-2272-2025 · Jul 7, 2025 · Open, Classified
  epoc BGEM BUN Test Card [25pk]. Material Number: 10736515.
• Z-1685-2025 · Mar 19, 2025 · Open, Classified
  epoc BGEM Crea Test Card (25 pk) for the epoc Blood Analysis System; Siemens Material Number (SMN): 10736382; epoc Software Version & Sensor Configuration: epoc Host SW v3.41.2, ep
• Z-1684-2025 · Mar 19, 2025 · Open, Classified
  epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System; Siemens Material Number (SMN): 10736515; epoc Software Version & Sensor Configuration: epoc Host SW v3.41.2, epo
• Z-0738-2025 · Nov 22, 2024 · Open, Classified
  epoc NXS Host; Siemens Material Number (SMN): 11413517(MX) ; Software Version Number: 4.14.9. Intended for use by trained medical professionals as an in vitro diagnostic device fo
• Z-0736-2025 · Nov 22, 2024 · Open, Classified
  epoc NXS Host; Siemens Material Number (SMN): 11413498(JP) ; Software Version Number: 4.14.9. Intended for use by trained medical professionals as an in vitro diagnostic device fo
• Z-0739-2025 · Nov 22, 2024 · Open, Classified
  epoc NXS Host; Siemens Material Number (SMN): 11413518 (ROW) ; Software Version Number: 4.14.9. Intended for use by trained medical professionals as an in vitro diagnostic device
• Z-0740-2025 · Nov 22, 2024 · Open, Classified
  epoc NXS Host; Siemens Material Number (SMN): 11413583(CN, KR) ; Software Version Number: 4.14.9. Intended for use by trained medical professionals as an in vitro diagnostic devic
• Z-0741-2025 · Nov 22, 2024 · Open, Classified
  epoc NXS Host; Siemens Material Number (SMN): 11413879(IN) ; Software Version Number: 4.14.9. Intended for use by trained medical professionals as an in vitro diagnostic device fo
• Z-0737-2025 · Nov 22, 2024 · Open, Classified
  epoc NXS Host; Siemens Material Number (SMN): 11413506 (CA); Software Version Number: 4.14.9. Intended for use by trained medical professionals as an in vitro diagnostic device fo
• Z-0735-2025 · Nov 22, 2024 · Open, Classified
  epoc NXS Host; Siemens Material Number (SMN): 11413497 (EU); Software Version Number: 4.14.9. Intended for use by trained medical professionals as an in vitro diagnostic device fo
• Z-0286-2025 · Sep 24, 2024 · Open, Classified
  epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System, SMN 10736515
• Z-0601-2024 · Oct 19, 2023 · Open, Classified
  epoc NXS Host Blood Analysis System, Siemens Material Numbers 11413497 (EU), 11413475 (US), 11413506 (CA), 11413517 (MX), 11413518 (ROW), 11413498 (JP), 11413583 (CN, KR), 11413879
• Z-2477-2023 · Jun 1, 2023 · Open, Classified
  epoc BGEM Crea Test Card with epoc Host SW v3.37.3, epoc NXS SW v4.10.6, Sensor Configuration 41.1
• Z-2476-2023 · Jun 1, 2023 · Open, Classified
  epoc BGEM BUN Test Card with epoc Host SW v3.37.3, epoc NXS SW v4.10.6, Sensor Configuration 41.1

…and 2 more.