Health product recall

MEDRAD® Centargo Injection System

Brand(s)
Last updated

Summary

Product
MEDRAD® Centargo Injection System
Issue
Medical devices - Performance
What to do

Customers will be notified with instructions to follow. 

Audience
Healthcare

Affected products

Affected products

Lot or serial number

Model or catalog number

MEDRAD® Centargo Injection System

Contact the manufacturer.

CENT-SYS-BAT

Issue

Centargo patient line sensor is a component of the Centargo injection system which detects a patient line. An investigation into reported air injection concerns found that, under certain special conditions, the patient line sensor may occasionally have difficulty detecting the presence of the patient line. This intermittent detection issue, combined with user reliance on automated system functions (such as auto-prime) and possible workflow inconsistencies, may slightly increase the likelihood of small air injections (1-10 ml). However, the overall risk remains low.

Recall start date: December 13, 2024

Additional information

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

Imaxeon Pty Ltd

Unit 1, 38-46 South Street, Rydalmere, New South Wales, Australia, 2116

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-76870

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