| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-01319-1 |
| Product Name/Description |
Acuity Central Monitoring Systems
Serial Numbers: TA02611, TA02611-HA, TA02612
ARTG Number: 100135 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
13/12/2013 |
| Responsible Entity |
|
| Reason/Issue |
There is a potential issue with the Acuity Central Monitoring Systems due to the performance of the NVIDIA NVS300X display cards, which may cause an unexpected CPU reboot to occur. During an Acuity reboot, centralised monitoring of some or all patients temporarily ceases, however bedside monitoring and alarming for any change of patient condition continues normally. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Welch Allyn will be providing replacement CPUs with unaffected NVS450 card installed to customers. |
| Contact Information |
02 9638 3000 - Welch Allyn Technical Support |