| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-01054-1 |
| Product Name/Description |
Volumed VP7000 Premium, Volumed VP7000 Classic Plus, Syramed SP6000 Premium and Syramed SP6000 Classic Plus
ARTG Number: 174698, 174697 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
14/10/2013 |
| Responsible Entity |
|
| Reason/Issue |
Medevco identified that in some rare cases the key input line can trigger random key presses. Even though the pumps correctly display the actual settings such as rate and volume infused at all times, random key presses can lead to alarms or undesired manipulations of the set values.
This recall action was carried out prior to approval of the recall strategy by the TGA. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Allied Medical is providing users with a software update to permanently correct the issue. |
| Contact Information |
08 9266 0100 - Allied Medical |