| 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 |
|
| 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 |