| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-01454-1 |
| Product Name/Description |
Brilliance iCT (Model 728306), Brilliance iCT SP (Model 728311) and IQon Spectral CT (Model 728332) Scanner systems
Manufactured beginning May 2009
ARTG: 98868 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
4/12/2017 |
| Responsible Entity |
|
| Reason/Issue |
There is a possibility that screws holding an internal portion of the gantry (Reaction Ring) to the scanner’s main bearing may come loose. If this occurs, the part(s) will not be expelled, however, a noise may be heard coming from the gantry. There is no potential for harm to the patient or operator due to this issue. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Philips is advising users that they will be inspecting the affected systems, tightening and replacing the reaction ring screws as needed at no additional cost. (Reference: Field Correction FCO 72800690)
This action has been closed out on 24/10/2019
This action has been closed out on 24/10/2019 |
| Contact Information |
1800 251 400 - Philips Customer Care |