Sokinox No Delivering And Monitoring System (2018-09-14)

Starting date:
September 14, 2018
Posting date:
September 28, 2018
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-67838

Affected products

Sokinox No Delivering And Monitoring System

Reason

Due to a pressure increase after the cylinder switch-over there are 2 possible issues identified:

  1. The cylinder status icon can change and erroneously indicate remaining gas in an empty NO gas cylinder.
  2. The alarm "NO cylinder 1 missing (or empty)" or "NO cylinder 2 missing (or empty)" can be deactivated. Since it was found that these pressure creeps were not fully addressed with SW version 1.3, version 1.3.1 was developed which contains additional improvements to further reduce the risk.

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