Health product recall

Epoc Blood Analysis System

Last updated

Summary

Product
Epoc Blood Analysis System
Issue
Medical devices - Performance
What to do

Contact the manufacturer if you require additional information. 

Affected products

Affected products

Lot or serial number

Model or catalogue number

Epoc Blood Analysis System

EPOC HOST 2, CA
HOST 2, EPOC, REFURBISHED

HH-1009-CA-00
HH-1R09-CA-00
HH-1009-00-00

Epoc Blood Analysis System - Computing Device With Custom Software

epoc NXS Host - 5553CA

11413506

Issue

Siemens Healthcare Diagnostics Inc. has confirmed an issue through complaint investigation. The issue has the potential to affect the recovery of po2 in quality control (qc) at elevation with barometric pressures <730 mmhg on epoc sensor configuration 41.1, epoc host 2 sw version 3.37.3 and epoc nxs host sw version 4.10.6, which were released on 17 October 2022.

Recall start date: December 19, 2022

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Chemistry
Health products - Medical devices - General hospital and personal use
Companies

Siemens Healthcare Limited

1577 North Service Road East, Oakville, Ontario, Canada, L6H 0H6

Published by
Health Canada
Audience
General public
Healthcare
Industry
Recall class
Type II
Identification number
RA-72408

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