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Type of Product	Medical Device
TGA Recall Reference	RC-2013-RN-00181-1
Product Name/Description	Advantx, Innova 2000, Innova 2100 IQ, Innova 3100, Innova 3100 IQ, Innova 4100, Innova 4100 IQ Cardiovascular X-ray Imaging Systems equipped with Video monitor Suspension model numbers 2236709, 2353620, 2223039-2 and 2270677-2 ARTG number: 93871
Recall Action Level	Hospital
Recall Action Classification	Class I
Recall Action Commencement Date	27/03/2013
Responsible Entity	GE Healthcare Australia Pty Ltd
Reason/Issue	There is a potential for the locking nut to loosen out of the Video Monitor Suspension yoke. This will not lead to an immediate fall of the suspended monitor since it will be held in place by the remaining bushing and a screw in the absence of the locking-nut.
Recall Action	Recall for Product Correction
Recall Action Instructions	A GE representative will contact the affected customers as soon as possible to arrange to check the potentially affected systems and implement permanent corrective actions to mitigate the potential for the failure mode occurring. Meanwhile, GE is asking customers to contact their local GE Healthcare Service Representative immediately if they observe any inappropriate performance or excessive movement of the monitor suspension yoke.
Contact Information	1800 659 465 - GE Customer Care Centre