| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00390-1 |
| Product Name/Description |
CentriMag Console (2nd Generation CentriMag Primary Console)
Model numbers: 201-30300, 201-90401, 201-90701
Serial numbers: L00694-0010, L06299-0007, L06309-0008, L07652-0001, L07656-0001, L07854-0001, L07936-0001, L06407-0004, L06407-0010, L06939-0001, L06939-0004, L06939-0007, L06939-0008
ARTG 161246
(Abbott Medical Australia Pty Ltd- Heart-lung bypass system module, console) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
24/05/2024 |
| Responsible Entity |
|
| Reason/Issue |
Internal testing showed that due to a component change, the CentriMag Console may not conform to the IEC 61000-4-5 standard. If subjected to a power surge above 1.8kV and up to 2.0 kV, the CentriMag Console may shut down completely without alarm. A power surge may be caused by, including, but not limited to the following: lightning strike, unregulated power switching, or faulty equipment. Pumping would cease and the patient would have to be switched to a backup. |
| Recall Action |
Product Defect Alert |
| Recall Action Instructions |
If the CentriMag Console shuts down without alarms or alerts present, customers are to follow Abbott Instruction for Use (IFU) for Console and Motor malfunction as described in the Section “Emergency / Troubleshooting”, and switch to a backup CentriMag Console which must be prepared as required backup components in the immediate vicinity.
When the backup CentriMag console is put into use, the previously used console can be restarted and set up as a backup console. |
| Contact Information |
0418497668 - Nicole Tognetti |