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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