Class 2 Device Recall epoc Blood Analysis System

• Date Initiated by Firm: November 22, 2024
• Date Posted: December 20, 2024
• Recall Status: Open, Classified
• Recall Number: Z-0734-2025
• Recall Event ID: 95809
• 510(K)Number: K200107
• Product Classification: Electrode measurement, blood-gases (pco2, po2) and blood ph - Product Code CHL
• Product: epoc NXS Host; Siemens Material Number (SMN): 11413475 (US); Software Version Number: 4.14.9. Intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial, venous or capillary whole blood in the laboratory or at the point of care.
• Code Information: Siemens Material Number: 11413475; UDI-DI: 00630414606095 Software Version Number: 4.14.9.
• Recalling Firm/ Manufacturer: Siemens Healthcare Diagnostics, Inc.; 333 Coney St; East Walpole MA 02032-1516
• For Additional Information Contact: Customer Service; 877-229-3711
• Manufacturer Reason for Recall: 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.
• FDA Determined Cause: Software design
• Action: Siemens issued Urgent Medical Device Correction (UMDC) letter to U.S. customers by FedEx beginning on November 22, 2024. Urgent Field Safety Notice (UFSN) was issued to OUS Siemens reporting sites with affected customers, for distribution and regional reporting to their local competent authorities beginning on November 22, 2024. Letter states reason for recall, health risk and action to take: Please review this letter with your Medical Director to determine the appropriate course of action, including for any previously generated results, if applicable. If you are a distributor, please ensure your customers receive this UMDC letter. To avoid the issue, please follow one of the options below: o Option 1: After completing a patient test, either log out or return to the home page before proceeding to the next patient test by pressing Close and Transmit button. o Option 2: Before starting a new test, follow the steps outlined in Section 6.19 Patient ID Lookup of the epoc System Manual with NXS Host and confirm the correct patient demographics. It is important to verify the demographics, as some of this data may be used for calculated analytes. If the demographics are incorrect, delete and re-enter the Patient ID and perform the PPID Lookup again. Complete and return the Field Correction Effectiveness Check Form attached to this letter within 30 days. Adverse reactions or quality problems experienced with the use of the affected products listed in the above table may be reported to the FDA s MedWatch Adverse Event Reporting program either online, by regular mail or by fax. Please retain this letter with your epoc System Manual with NXS Host or place the letter near the affected instrument for reference. Please also forward this letter to those who may have received this product. For any questions, you may call Siemens Healthineers Technical Solutions Center at 877-229-3711, available daily from 7:00 AM to 11:00 PM EST. The issue will be resolved in the
• Quantity in Commerce: 6,738 units
• Distribution: Nationwide Foreign: Albania Angola Argentina Australia Austria Bahrain Bangladesh Belarus Belgium Bolivia Bosnia and Herzegovina Brazil Cambodia Canada Chile China Colombia Croatia Czech Republic Denmark Ecuador Egypt Estonia Finland France Germany Ghana Greece Guadeloupe Hong Kong Hungary Iceland India Indonesia Iraq Ireland Israel Italy Japan Jordan Kazakhstan Kuwait Latvia Lithuania Luxembourg Macau Madagascar Malaysia Mexico Monaco Mongolia Morocco Myanmar Netherlands New Caledonia New Zealand Norway Paraguay Peru Philippines Poland Portugal Republic Korea Romania Russian Federation Saudi Arabia Singapore Slovakia Slovenia South Africa Spain Sri Lanka Swaziland Sweden Switzerland Thailand Tunisia Turkey Ukraine United Arab Emirates United Kingdom Great Britain Uruguay Vietnam
• Total Product Life Cycle: TPLC 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) Database: 510(K)s with Product Code = CHL