| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-01022-1 |
| Product Name/Description |
Philips Spectral CT systems or the Spectral CT on Rails systems
Spectral CT on Rails systems
Product code: 728334
Device identifier: 00884838103627
Spectral CT systems
Product codes: 728333 and 728340
Device identifier: 00884838101111
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 |
13/11/2024 |
| Responsible Entity |
|
| Reason/Issue |
Philips has identified two problems that could affected the performance of the Philips Spectral CT systems or the Spectral CT on Rails systems.
Problem 1: An interruption during the "get ready for scan" stage of a scan or an interruption during air calibration may occur. If this occurs it may require a system reboot or if this occurs during a scan it could result in a partial set of images and patient may require a rescan.
Problem 2: A synchronisation problem in the Firmware can result in an image quality problem where a dead layer will appear as a ring/band artifact. If this occurs during a scan it could result in a partial set of images and patient may require a rescan.
Philips has not received any reports of injury or serious harm associated with these problems. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Philips will contact customers to schedule a time for a Philips Field Service Engineer (FSE) to install the solution to resolve these problems.
In the interim customers can continue to use the devices in accordance with the intended use. If problem one occurs customers can retry the scan and if that fails reboot the system. If problem two occurs customers can retry the scan. |
| Contact Information |
1800 251 400 - Philips Service Delivery Team |