| 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 |
|
| 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 |