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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 FirmDecember 12, 2022
Date PostedMarch 03, 2023
Recall Status1 Open3, Classified
Recall NumberZ-1215-2023
Recall Event ID 91639
510(K)NumberK200107 
Product Classification Electrode measurement, blood-gases (pco2, po2) and blood ph - Product Code CHL
Productepoc Host 2 as follows: Product SMN epoc NXS Host, US 11413475 epoc NXS Host, EU 11413497 epoc NXS Host, Japan 11413498 epoc NXS Host, Canada 11413506 epoc NXS Host, ROW 11413518 epoc NXS Host, China-Korea 11413583
Code Information Host Software Version /Sensor Configuration: 4.10.6/41.1 Product Description Siemens Material Number (SMN) (UDI-DI) epoc NXS Host, US 11413475 00630414606095; epoc NXS Host, EU 11413497 00630414605760; epoc NXS Host, Japan 11413498 00630414605814; epoc NXS Host, Canada 11413506 00630414605821; epoc NXS Host, ROW 11413518 00630414605678; epoc NXS Host, China-Korea 11413583 00630414612447 .
Recalling Firm/
Manufacturer		 Siemens Healthcare Diagnostics Inc
2 Edgewater Dr
Norwood MA 02062-4637
For Additional Information ContactSAME
781-269-3000
Manufacturer Reason
for Recall		pO2 High Recovery in Quality Control When Adjusted for Barometric Pressure
FDA Determined
Cause 2		Under Investigation by firm
ActionSiemens has issued an Urgent Medical Device Correction POC 23-004.A.US on December 12, 2022 and Urgent Field Safety Notice POC 23-004.A.OUS to customers informing them of the issue and providing workaround for customers to use until the affected sensor configuration/software version expires on June 12, 2023. The next sensor configuration with the fix and its corresponding sw version will be available to customers in April 2023. Letter states reason for recall, health risk and action to take: " 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. " If you perform QC tests at barometric pressures equal to or above 730 mmHg (97 kPa), no additional action is required. " If you perform QC tests at barometric pressures less than 730 mmHg (97 kPa), apply barometric correction factors before comparing the gas readings with the published value assignments. ***Important Note*** The above barometric correction factor should be applied only to epoc System Software sensor configuration 41.1, epoc Host 2 SW Version 3.37.3 and epoc NXS Host SW Version 4.10.6, which expires June 12, 2023. Following the expiration of this sensor configuration and the software version refer to the epoc System Manual Section 9.5.1 for the appropriate Barometric Correction factor to apply." Please review this letter with your Medical Director." Please retain this letter with your laboratory records and forward this letter to those who may have received the affected product. Questions, please contact your Siemens Healthineers Technical Solution Center or your local Siemens Healthineers technical support representative.
Quantity in Commerce4,369 units
DistributionNationwide Foreign: Algeria Argentina Australia Austria Bahrain Belarus Belgium Bolivia Brazil Cambodia Canada Chile China Colombia Croatia Czech Republic Denmark Ecuador Egypt Estonia Finland France Fren.Polynesia Georgia Germany Greece Guadeloupe Hong Kong Hungary Iceland India Indonesia Iran Ireland Israel Italy Japan Jordan Kazakhstan Kenya Kuwait Laos Latvia Lithuania Luxembourg Malaysia Mali Martinique Mexico Myanmar Netherlands New Caledonia New Zealand Norway Papua Nw Guinea Peru Philippines Poland Portugal Qatar Republic Korea Reunion Romania Russian Fed. San Marino Singapore Slovakia Slovenia Solomon Islands South Africa Spain Sweden Switzerland Taiwan Thailand Tunisia Turkey U.A.E. Ukraine United Kingdom Uruguay Vietnam
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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