| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2012-RN-00710-3 |
| Product Name/Description |
Alaris PC Unit (General purpose infusion pump)
Model Number: 8015
PC units manufactured or serviced after January 2011 that contain PC Unit power supply board: P/N TC10005122
Multiple serial numbers affected
ARTG Number: 146664 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
12/07/2012 |
| Responsible Entity |
|
| Reason/Issue |
The manufacturer has identified a potential risk associated with a component on the PC unit power supply board which is causing an error code (120, 4630) "System Error" or "Missing Battery Error" at start up or prevent programming changes if the problem occurs during use. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
If error observed remove PC unit from use. PC Unit boards replaced. |
| Contact Information |
02 9624 9006 - Melissa Robins |