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epoc NXS Host recallZ-0737-2025 · Siemens Healthcare Diagnostics, Inc. · initiated Nov 22, 2024

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Siemens Healthcare Diagnostics, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 root cause category: Software design

What the company is doing

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

Recall details

Recall number
Z-0737-2025
Status
Open, Classified
Initiated by the company
Nov 22, 2024
Posted by the FDA
Dec 20, 2024
Recalling firm
Siemens Healthcare Diagnostics, Inc.
Quantity
320 units
Product code
CHL
FDA submissions
K200107
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

Product description

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 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 (models, lots, serial numbers)

Siemens Material Number: 11413506; UDI-DI: 00630414605821; Software Version Number: 4.14.9.

Other devices under the same FDA submission

1 device cleared under K200107 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 95809).

Sources and updates

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