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Type of Product Medical Device
TGA Recall Reference RC-2014-RN-00407-1
Product Name/Description Kenex suspension arm with radiation shield and/or surgical lamp

ARTG Number: 136957
Recall Action Level Hospital
Recall Action Classification Class I
Recall Action Commencement Date 4/04/2014
Responsible Entity GE Healthcare Australia Pty Ltd
Reason/Issue GE Healthcare has recently become aware of an improper installation of the Kenex suspension arm of a radiation shield. The suspension arm was not installed by GE Healthcare per specified installation requirements. There is no deficiency associated with the Kenex suspension arm. There has been one reported incident of a radiation shield falling from the ceiling causing a minor injury.
Recall Action Recall for Product Correction
Recall Action Instructions GE Healthcare is inspecting all affected systems to verify that the Kenex suspension radiation shields and surgical lamps are properly installed. A GE representative will contact customers to arrange for the inspection. Any affected systems will be corrected.
Contact Information 1800 659 465 - GE Healthcare National Call Centre