SOKINOX NO DELIVERING AND MONITORING SYSTEM (2021-05-17) | Recall Monitor

SOKINOX NO DELIVERING AND MONITORING SYSTEM (2021-05-17)
Health Products
May 17th, 2021 @ 12:00 AM

Basic Details

Category: Medical Device
Issue: Medical Devices
Audience: General Public, Hospitals, Healthcare Professionals
Department: Health Canada
Alert type: Medical Device Recall
Hazard classification: Type II

Products

Lot or serial numberCompaniesBrand nameModel or catalog number
More than 10 numbers, contact manufacturer. 
Manufacturer
Maquet Critical Care AB
Rontgenvagen 2
Solna
17154
SWEDEN
SOKINOX NO DELIVERING AND MONITORING SYSTEM6694550

Introduction

Affected Products 

SOKINOX NO DELIVERING AND MONITORING SYSTEM

Reason

The manufacturer received a limited number of user reports with “Flow sensor line blocked” alarm, when the problem is in the flow sensor board. The customer can in conventional ventilation use the backup system but if they are in HFOV therapy that option is not available.  All customers shall be informed of this issue and instructed in how to act if this occur via the enclosed Customer Letter.

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