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Type of Product Medical Device
TGA Recall Reference RC-2014-RN-00648-1
Product Name/Description Axiom Artis and Artis Zee Systems with hand switch (Fluoroscopic angiographic X-ray system)

Hand Switch Material Number: 3771750

ARTG Numbers: 102173 and 102177
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 17/06/2014
Responsible Entity Siemens Ltd
Reason/Issue A problem may occur if the connection between cable connection and hand switch is contaminated with a large amount of fluid. In a worst case situation, uncontrolled release of a x-ray image may happen. The system terminates uncontrolled X-ray after a short period.
Recall Action Recall for Product Correction
Recall Action Instructions Siemens service personnel will contact affected customers to organise for the removal of the cable extension. The hand switch will be directly connected to the patient table preventing the issue from occurring.
Contact Information 1800 310 300 - Siemens Technical Support Centre