| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00304-1 |
| Product Name/Description |
Philips Spectral CT7500
Product code: 728333
Device Identifier numbers: 00884838101111, 00884838111103
ARTG 423851
(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 |
16/04/2024 |
| Responsible Entity |
|
| Reason/Issue |
The HIB-CIB cable on the NOAH couch may wear unexpectedly over time.
During vertical couch motion, if the HIB-CIB cable has been damaged, the system may engage the Emergency Stop intermittently.
If the Emergency Stop is engaged both motion and X-rays will stop.
If this occurs during a scan it could result in a partial set of images, and a patient rescan may be required.
Philips has not received any reports of injury or serious harm associated with this problem to date. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Philips will contact the affected customers to schedule a time for a Philips Field Service Engineer (FSE) to visit the impacted site and install the solution to resolve the problem.
In the meantime, customers may continue to use the Philips CT system(s) in accordance with the intended use.
If they experience the Emergency Stop opening intermittently during vertical couch motion, they must contact the local Philips representative. |
| Contact Information |
1800 251 400 - Philips Service Delivery Team |