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Type of Product	Medical Device
TGA Recall Reference	RC-2014-RN-00475-1
Product Name/Description	Brilliance CT series (6, 10, 16, 16 Power, 40, 64, Big Bore, iCT, iCT SP), Ingenuity CT, Ingenuity Core, Ingenuity Core128, Ingenuity Flex, MX8000 Dual v. EXP ARTG Number: 98868
Recall Action Level	Hospital
Recall Action Classification	Class I
Recall Action Commencement Date	24/04/2014
Responsible Entity	Philips Electronics Australia Ltd
Reason/Issue	Philips have found that if the service latch is not properly secured during servicing of the device, the table top's subframe becomes free floating causing unintended horizontal motion during use. There is a risk of serious injury to the patient and Operator/Technician as a result of the table top free floating. For the patient: - There is a potential for disconnection or movement of invasive medical devices such as I.V.’s, tracheostomies, and surgical drains For the Operator/Technician: - There is a potential for pinch point on the subframe; and - A potential for entrapment between the table and the gantry if the Operator/Technician stands between them to shift the patient forward
Recall Action	Recall for Product Correction
Recall Action Instructions	Philips is advising their customers to contact their Field Service Engineer, if horizontal free-floating couch motion is experienced. This action has been closed-out on 11/04/2016.
Contact Information	1800 251 400 - Philips Customer Care Centre