Health product recall

Infinity Acute Care

Last updated

Summary

Product
Infinity Acute Care
Issue
Medical devices - Software defect
What to do

Contact the manufacturer if you require additional information.

Affected products

Affected Products Lot or Serial Number Model or catalog number
Evita V300 More than 10 numbers, contact manufacturer. 8420400
Infinity Acute Care System Workstation Neonatal Care More than 10 numbers, contact manufacturer. 8417400
Infinity Acute Care Workstation Critical Care More than 10 numbers, contact manufacturer. 8416400

Issue

The abovementioned ventilators use specially hardened operating system. Components of the imbedded operating systems can no longer be updated, and any potential vulnerabilities cannot be addressed. Therefore, they are not prepared against potential cyber security threats to the same extent as newer.

Recall start date: Feb 7, 2022

 

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Anaesthesiology
Health products - Medical devices - Cardiovascular
Companies

Draegerwerk Ag & Co. Kgaa

Moislinger Allee 53-55, Lubeck

Germany, 23542

Published by
Health Canada
Audience
General public
Health professionals
Hospitals
Recall class
Type II
Identification number
RA-63982