| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2012-RN-01104-1 |
| Product Name/Description |
Monitors B20 or B40 Software version VSP-A_1.10 (or earlier) (Multiparameter Patient Monitor)
ARTG Number: 92726 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
29/10/2012 |
| Responsible Entity |
|
| Reason/Issue |
The 'V Tachy' and 'V Fib' alarms of Monitor B20 or B40 in NEONATAL mode are disabled due to a design issue. The user manual says that the monitor will detect these alarms. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Clinicians should stop using the monitors in NEONATAL mode until the sponsor provides a software solution to correct the problem. |
| Contact Information |
1300 722 229 - National Service and Support Centre |