| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-01470-1 |
| Product Name/Description |
Brilliance iCT/iCT SP/Big Bore/6/10/16/16P/40/64 and Ingenuity CT/Core/Core128
The following CT products manufactured from 1 January 2006 to 30 June 2014 are potentially affected:
Brilliance iCT/Brilliance iCT SP
Brilliance Big Bore Oncology/Brilliance Big Bore Radiology
Brilliance 6/Brilliance 10/Brilliance16/Brilliance 16P/Brilliance 40/Brilliance 64
Ingenuity CT/Ingenuity Core/Ingenuity Core128
ARTG Number: 98868 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
10/11/2016 |
| Responsible Entity |
|
| Reason/Issue |
The patient support table top may fail to move in the horizontal direction when it is commanded to do so during CT scans, due to a potential mechanical linkage failure. The system cannot automatically detect this failure to abort the scan or to alert the user. Of the 5000 CT systems potentially affected, there have been 2 occurrences of this failure mode in the past 10 years. This issue could result in undesired radiation due to multiple exposures of the same anatomical region caused by failed couch motion during CT scanning. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
A Philips Field Service Engineer will contact affected customers to schedule the updates. In the interim, customers are advised to follow the warning in the Instruction for Use: “During all movements of the gantry and the patient table (automatic and manual), keep the patient under continuous observation.”
If the patient table is not moving when it is commanded to move during CT scan, abort the scan by pressing the Pause button or Emergency stop actuator and call the local Philips representative.
This action has been closed out on the 12/11/2018. |
| Contact Information |
1800 251 400 - Philips Customer Care Centre |