CARESCAPE Respiratory Modules (2019-09-30)

Starting date:

September 30, 2019

Posting date:

November 1, 2019

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-71449

Last updated: 2019-11-01

• 
  Reason
• 
  Affected products

Affected Products

CARESCAPE Respiratory Modules

Reason

Displayed End Tidal Oxygen (EtO2) and Fraction of Inspired Oxygen (FiO2) values may be incorrect which could cause up to 50% measurement error in the EtO2/FiO2 values. This issue can occur in the O2 sensor of the CARESCAPE Respiratory Modules and Airway Gas Options.

Affected products