SERVO-i Ventilator System (2018-03-20)

Starting date:

March 20, 2018

Posting date:

April 13, 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-66400

• 
  Reason
• 
  Affected products

Affected products

SERVO-i Ventilator System

Reason

Under certain conditions, an internal communication error might prevent the safety valve to close automatically. As a consequence, ventilation will stop a high priority alarm, as well as clinical alarms, will be triggered. We have no reports of any permanent injuries. This issue will stop ventilation, the safety valve open, thus allowing the patient to breathe freely, but without ventilator support. The high priority technical error alarm TE 11 will be activated simultaneously with other clinical alarms.

Affected products