Carescape R860 (2018-10-04)

Starting date:

October 4, 2018

Posting date:

October 26, 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-68094

• Reason
• Affected products

Affected products

Carescape R860

Reason

The ventilator Inspiratory Safety Guard (ISG) may disconnect from the breathing circuit pathway or from the ventilator outlet port. This disconnection could create a loss of ventilation which may lead to inadequate oxygenation for patients, increasing the possibility of hypoxia.

Affected products