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

• Reason
• Affected products

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