Public recall detail

MEDRAD® Centargo Injection System

2025-01-28

medium
Recall Safety notice
Quick summary

Quick summary: MEDRAD® Centargo Injection System. Date: 2025-01-28.

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

Quick summary: MEDRAD® Centargo Injection System. Date: 2025-01-28.

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

BrandImaxeon Pty Ltd
ProductMEDRAD® Centargo Injection System
IssueMedical devices - Performance
Recall classType II
IdentificationRA-76870

Affected products

ProductMEDRAD® Centargo Injection System
LotContact the manufacturer.
ModelCENT-SYS-BAT
Serial numberContact the manufacturer.
DescriptionMEDRAD® Centargo Injection System

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

What you should do

  • Customers will be notified with instructions to follow.
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - Cardiovascular
CompaniesImaxeon Pty Ltd Unit 1, 38-46 South Street, Rydalmere, New South Wales, Australia, 2116
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-76870
Background{}
CompaniesImaxeon Pty Ltd Unit 1, 38-46 South Street, Rydalmere, New South Wales, Australia, 2116
AudiencesHealthcare
Source updated2025-01-28

Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.

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