Recall Z-0601-2024 ยท CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Siemens Healthcare Diagnostics Inc
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 (IN) with software versions from 4.9.4 to the current version 4.11.11
| Date | Dec 21, 2023 (initiated Oct 19, 2023) |
| Status | Open, Classified |
| Reason | 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 err |
| Root cause | Software design |
| Action | An 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 Delet |
| Quantity | 10,183 devices |
| Distribution | US Nationwide. Global Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K200107 | epoc Blood Analysis System Epocal, Inc., Jun 5, 2020 |