| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00597-1 |
| Product Name/Description |
Ingenuity Core128 CT System
Serial Number: 320247
ARTG Number: 98868 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
6/05/2016 |
| Responsible Entity |
|
| Reason/Issue |
During production two different length fasteners were found to be made of stainless steel rather than the specified alloy steel. The nonconforming fasteners may have been used to manufacture Ingenuity CT systems. The fasteners are used to secure sub-components of the adjustment cradle within the system gantry.
Analysis has concluded that the nonconforming fasteners continue to meet the tensile safety factor requirements for the application. However given the material characteristics of stainless steel, these fasteners may not be re-used (re-torqued). Since the adjustment cradle requires periodic adjustment, it is expected that the nonconforming fasteners would require re-torqueing at some point during the system’s lifetime.
Repeated re-torqueing of the stainless steel fasteners could introduce stresses that approach the ultimate yield strength of the fasteners. There have been no reports of injuries. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Philips is advising users that a field service technician will replace the affected screws on all affected systems.
This action has been closed-out on 27/03/2018. |
| Contact Information |
1800 251 400 - Philips Customer Care Centre |