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

Starting date:
May 17, 2021
Posting date:
May 26, 2021
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Hospitals, Healthcare Professionals
Identification number:
RA-75667

Last updated:

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.

Affected products

SOKINOX NO DELIVERING AND MONITORING SYSTEM

Lot or serial number
  • More than 10 numbers, contact manufacturer. 
Model or catalog number
  • 6694550
Companies
Manufacturer
Maquet Critical Care AB
Rontgenvagen 2
Solna
17154
SWEDEN