epoc NXS Host; Siemens Material Number (SMN): 11413497 (EU); Software Version Number: 4.14.9. Intended for use by traine

FDA device recall Z-0735-2025 · posted 2024-12-20 · Open, Classified

Recall details

Recalling firm

Siemens Healthcare Diagnostics, Inc.

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.

Action taken

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

Root cause

Software design

Status

Open, Classified

Product code

CHL

Quantity affected

3,011 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 Denm

Date initiated

2024-11-22

Date posted

2024-12-20

Location

East Walpole, MA

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