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Type of Product Medical Device
TGA Recall Reference RC-2014-RN-00426-1
Product Name/Description MEDRAD Continuum Infusion Pump

Systems ditributed prior to March 2008

ARTG Number: 94004
Recall Action Level Hospital
Recall Action Classification Class I
Recall Action Commencement Date 11/04/2014
Responsible Entity Imaxeon Pty Ltd
Reason/Issue Bayer HealthCare is recalling brackets used to mount the Continuum pump on the IV pole distributed with non-wireless versions of Medrad Continuum MR Infusion Systems prior to March 2008. These brackets are being recalled because of a potential safety risk in the MRI environment associated with locking pins which may become damaged and not restrain the pump from being attracted to the MRI magnet.
Recall Action Recall
Recall Action Instructions Imaxeon is requesting their customers to inspect their bracket immediately. If a bracket has a damaged pin end users are advised to cease use immediately and remove from the MR scan room. Undamaged brackets should be inspected every time a Continuum Pump is installed or removed until a replacemnt bracket is supplied.
Contact Information 02 8845 4999 - Imaxeon Pty Ltd