Siemens Healthcare Diagnostics Inc epoc Host 2 as follows: Product SMN epoc Host 10736387 epoc Host 2, Canada 10736388 epoc Host 2, China 10736389 epoc Host 2, Japan 10736390 epoc Host 2, Refurbished 10736393 epoc Host 2, Canada, Refurbished 10736394 epoc Host 2, Japanese, Refurbished 10736395 epoc Host 2, Chinese, Refurbished 10736433 epoc Host 2, US (MC55X) 11413524 epoc Host 2, ROW (MC55X) 11413528 epoc Host 2, India (MC55X) 11413541 epoc Host 2, China (MC55X) 11413542 epoc Hos Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

pO2 High Recovery in Quality Control When Adjusted for Barometric Pressure

Recommended Action

Per FDA guidance

Siemens 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.