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Type of Product Medical Device
TGA Recall Reference RC-2012-RN-01159-1
Product Name/Description SonoSite NanoMaxx Ultrasound System, version

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 Fujifilm Sonosite Australasia Pty Ltd
Reason/Issue During design verification testing, it was found that when using its NanoMaxx ultrasound system configured with system software ARM version (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