| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2023-RN-00268-1 |
| Product Name/Description |
Philips Spectral CT 7500
ARTG 321687
(Philips Electronics Australia Ltd - X-ray system, diagnostic, computed tomography, full-body) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
28/03/2023 |
| Responsible Entity |
|
| Reason/Issue |
Philips has become aware of a potential safety issue when using the Unload Pedal of the foot switch on the Spectral CT 7500 system. Pressing the Unload Pedal of the foot switch to perform the unload function may cause entrapment of the operator’s foot. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Customers are advised to:
- Immediately stop using the Unload Pedal of the Foot Switch until Philips installs a solution on the system. Instead of using the Unload Pedal, please use the Unload Patient function on the Gantry Control Panels, or use other Table In/Out, Up/Down functions on the Gantry Control Panels, CT Scan Control Box, or Hardware Interventional Controls to fulfill the normal patient unloading function, as instructed in the IFU.
- Use of Load Pedal, and Free-Float Pedal of Foot Switch, can continue as they are not affected.
- Philips will make contact to organise a Field Service Engineer to visit the site and install the solution to resolve the issue.
- Complete acknowledgment form and return via email or fax within 3 business days, even if there is no affected stock.
This action has been closed out on 14/12/2023 |
| Contact Information |
1800 251 400 - Philips Service Delivery Team |