| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2012-RN-01159-1 |
| Product Name/Description |
SonoSite NanoMaxx Ultrasound System, version 60.80.101.025
Model Number: P11111-35
ARTG Number: 118714 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
15/11/2012 |
| Responsible Entity |
|
| Reason/Issue |
During design verification testing, it was found that when using its NanoMaxx ultrasound system configured with system software ARM version 60.80.101.025 (referred to as Nano 1.0.5) when the USB printer is selected from the pull down menu and the Print command is selected, the Status bar will freeze as expected during spooling. However, once the spooling is complete the Status car does not unfreeze and information is not updated. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Customers to contact SonoSite Technical support to arrange a software upgrade. |
| Contact Information |
1300 663 516 - SonoSite Australia & New Zealand |