| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00463-1 |
| Product Name/Description |
Incisive CT System
REF: 728143, 728144
Device Identifier: 00884838085015, 00884838105508
Multiple Serial Numbers
ARTG 352131
(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 |
6/06/2024 |
| Responsible Entity |
|
| Reason/Issue |
A hardware problem with a metal mounting box on the rotating scanner on rotor (heat change box) located within the Incisive CT system has been identified. This component’s structural integrity may become compromised, resulting in potential contact with other gantry components during rotation. Other components could be damaged due to the contact with the detached component.
If this problem occurs, a loud noise will be emitted and the system will shut down. The cover may become displaced if the following sequence occurs:
· Damaged component(s) come loose
· The damaged component(s) contact other components in the system and cause them to break
· A broken component makes contact with the top right gantry cover
The displaced cover could create a small gap allowing a fragment of a damaged component to be expelled, that could cause injury, such as pain (body or neck), laceration, or eye injury. If the Incisive CT system shuts down during clinical scanning, a rescan may be needed.
|
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Philips will contact you to schedule a time for a Field Service Engineer (FSE) to visit your site and install a solution to address the issue.
Customers can continue to use the system in accordance with its intended use. If you need to remain in the room for the duration of a scan, Philips recommends using protective eyewear. |
| Contact Information |
1800 251 400 - Philips Service Delivery Team |