Print version of this report
Type of Product Medical Device
TGA Recall Reference RC-2014-RN-00474-1
Product Name/Description Brilliance CT 16, 64, Big Bore iCT, Ingenuity CT, Ingenuity Core, Ingenuity Core128, Ingenuity Flex

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 two potential issues that may result in the subframe of the table top becoming free floating and causing unintended, horizontal motion. The two potential issues are:
1. Service latch may not be properly secured;
2. Service latch threaded rod may be fractured.

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
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 stop using the system if horizontal free-floating couch motion is experienced during normal clinical use. The threaded rob will be replaced in all affected devices. This action has been closed-out on 12/02/2016.
Contact Information 1800 251 400 - Phillips Customer Care Centre