Epoc Blood Analysis System
Brand(s)
Last updated
Summary
Product
Epoc Blood Analysis System
Issue
Medical devices - Performance issue
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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