Public recall detail

Epoc Blood Analysis System

2022-12-23

medium
Recall Safety notice
Quick summary

Quick summary: Epoc Blood Analysis System. Date: 2022-12-23.

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

Quick summary: Epoc Blood Analysis System. Date: 2022-12-23.

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

BrandSIEMENS HEALTHCARE LIMITED
ProductEpoc Blood Analysis System
IssueMedical devices - Performance
Recall classType II
IdentificationRA-72408

Affected products

ProductEpoc Blood Analysis System
LotEPOC HOST 2, CA HOST 2, EPOC, REFURBISHED
ModelHH-1009-CA-00 HH-1R09-CA-00 HH-1009-00-00
Serial numberEPOC HOST 2, CA HOST 2, EPOC, REFURBISHED
DescriptionEpoc Blood Analysis System
ProductEpoc Blood Analysis System - Computing Device With Custom Software
Lotepoc NXS Host - 5553CA
Model11413506
Serial numberepoc NXS Host - 5553CA
DescriptionEpoc Blood Analysis System - Computing Device With Custom Software

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

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceGeneral public Healthcare Industry
CategoryHealth products - Medical devices - Chemistry Health products - Medical devices - General hospital and personal use
CompaniesSiemens Healthcare Limited 1577 North Service Road East, Oakville, Ontario, Canada, L6H 0H6
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-72408
Background{}
CompaniesSiemens Healthcare Limited 1577 North Service Road East, Oakville, Ontario, Canada, L6H 0H6
AudiencesGeneral public Healthcare Industry
Source updated2022-12-23

Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.

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