epoc Host 2 as follows recallZ-1215-2023 · Siemens Healthcare Diagnostics Inc · initiated Dec 12, 2022

Why it was recalled

pO2 High Recovery in Quality Control When Adjusted for Barometric Pressure

FDA root cause category: Under Investigation by firm

What the company is doing

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.

Recall details

Recall number

Z-1215-2023

Status

Open, Classified

Initiated by the company

Dec 12, 2022

Posted by the FDA

Mar 3, 2023

Recalling firm

Siemens Healthcare Diagnostics Inc

Quantity

4,369 units

Product code

CHL

FDA submissions

K200107

Distribution

Nationwide 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

Product description

epoc 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

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

• epoc NXS Host 11413475

  Epocal Inc · ACID, LACTIC, ENZYMATIC METHOD
  2 recalls6 reports

Other products in the same recall event

The FDA groups related products into one recall event (event 91639).

• Z-1214-2023 · Open, Classified
  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, Refurbi…