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Type of Product Medical Device
TGA Recall Reference RC-2014-RN-00136-1
Product Name/Description AXIOM Artis Systems (fluoroscopic angiographic x-ray system)

Catalogue Numbers: 7412807, 7728392

Serial Numbers: 35031, 44018

ARTG Number: 102173
Recall Action Level Hospital
Recall Action Classification Class I
Recall Action Commencement Date 7/02/2014
Responsible Entity Siemens Ltd
Reason/Issue AXIOM Artis Systems with certain serial numbers are using flat detector cooling unit with inappropriate connectors that may leak. This might cause a system failure resulting in a drop out of the gantry system.
Recall Action Recall for Product Correction
Recall Action Instructions All connectors will be checked for leak tightness and an additional protection unit will be installed by Siemens' technicians. This will prevent leakages in the connector and therefore, the potential drop out of the gantry system can be avoided.
Contact Information 1800 310 300 - Siemens Technical Support Centre