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U.S. Department of Health and Human Services

Class 2 Device Recall epoc NXS Host

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 Class 2 Device Recall epoc NXS Hostsee related information
Date Initiated by FirmOctober 19, 2023
Date PostedDecember 21, 2023
Recall Status1 Open3, Classified
Recall NumberZ-0601-2024
Recall Event ID 93388
510(K)NumberK200107 
Product Classification Electrode measurement, blood-gases (pco2, po2) and blood ph - Product Code CHL
Productepoc NXS Host Blood Analysis System, Siemens Material Numbers 11413497 (EU), 11413475 (US), 11413506 (CA), 11413517 (MX), 11413518 (ROW), 11413498 (JP), 11413583 (CN, KR), 11413879 (IN) with software versions from 4.9.4 to the current version 4.11.11
Code Information UDI-DI: 00630414605760 00630414606095 00630414605821 00630414605838 00630414605678 00630414605814 00630414612447 00630414631028; All serial numbers.
Recalling Firm/
Manufacturer		 Siemens Healthcare Diagnostics Inc
2 Edgewater Dr
Norwood MA 02062-4637
For Additional Information Contact
877-229-3711
Manufacturer Reason
for Recall		Siemens Healthcare Diagnostics Inc. has confirmed a potential issue that could occur under certain conditions, a software problem is causing erroneous results to be printed. When the results are run on the epoc NXS Host and Delete Blood Tests feature is enabled, the results that are generated at the time of testing are correct; however, when this issue occurs, results that are printed, saved and/or transferred to a data manager, may include unselected analytes that are from a previous patient or QC test. The worst possible outcome may result in a failure to diagnose hyperkalemia, due to an erroneous depressed potassium level or inappropriate treatment to hyperglycemia due to erroneous glucose reading.
FDA Determined
Cause 2		Software design
ActionAn Urgent Medical Device Correction notification letter dated October 2023 was sent to customers. Actions to be Taken by the Customer Please review this letter with your Medical Director to determine the appropriate course of action, including for any previously generated results, if applicable. To mitigate this issue, follow the instructions below to set Delete Blood Test settings to NEVER and continue using device as normal. To change the device setting: 1. Log in as Administrator 2. Select Settings 3. Select General Settings 4. In the General Settings, scroll to the bottom and select Delete Blood Tests 5. Set Delete Blood Tests to Never. If a Data Manager is in use, the Delete Blood Tests option must be changed on the Data Manager. Do NOT make the change on the epoc Host as the setting will be overwritten on the next synchronization. The Delete Blood Tests option may have a different name depending on the Data Manager in use. Please contact the Data Manager customer service for additional support, if needed. Complete and return the Field Correction Effectiveness Check Form attached to this letter within 30 days. If you are a distributor, please ensure your customers receive this UMDC letter. Please retain this letter with your laboratory records and forward this letter to those who may have received this product. This issue will be corrected with the next NXS software version (4.12.XX) which must be installed by December 12, 2023, when current software version (4.11.11) expires. We apologize for the inconvenience this situation may cause. If you have any questions, please contact your Siemens Healthineers Customer Care Center or your local Siemens Healthineers technical support representative.
Quantity in Commerce10,183 devices
DistributionUS Nationwide. Global Distribution.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = CHL
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