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Type of Product	Medical Device
TGA Recall Reference	RC-2018-RN-00226-1
Product Name/Description	Philips CT couches used on Brilliance CT Big Bore, Brilliance CT Big Bore Oncology, Brilliance iCT, Brilliance iCT SP, Ingenuity Core, Ingenuity Core128, Ingenuity CT, Ingenuity Flex systems Serial Numbers: 901001 - 901992,911001 - 911221, 921001 - 921369, 931001 - 931044, 941001 - 941137, 951001 - 951130 ARTG Numbers: 98868 (Philips Electronics Australia - X-ray system, diagnostic, computed tomography, full-body)
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	14/03/2018
Responsible Entity	Philips Electronics Australia Ltd
Reason/Issue	Upon closing the Emergency Stop (E-STOP) the system performs an internal check. As a result of the motion controller in the couch, there is a delay in the response to the internal check. This delay may cause the couch carbon top to enter a free float state, which may allow it to move during patient load or unload activities. This free float motion results in the ESTOP being opened due to the unexpected couch motion. This issue occurs frequently after closing E-STOP. The motion controller in the couch detects a power problem and disables the horizontal motor, which allows the couch top to free-float*. *The term free float refers to the couch top being in a state that is not locked in position by the brake or being moved in a controlled fashion (manual or automatic motion).
Recall Action	Product Defect Correction
Recall Action Instructions	Philips is advising users that once the E-stop has been closed the operator/technologist must initiate a brief horizontal motion (in or out) using any of the operator control panels, CT-Box or tape/foot switches. This action will ensure the couch carbon top (upper pallet) is in a controlled state. Philips will be conducting an update to permanently correct the issue. This action has been closed out on 30/08/2019
Contact Information	1800 251 400 - Customer Service Support