| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00190-1 |
| Product Name/Description |
Philips Incisive CT
Model numbers: 728144, 728143
UDI: (01)00884838105508(21), (01)00884838085015(21)
Serial numbers: 550187, 550241 and 500408
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 |
8/03/2024 |
| Responsible Entity |
|
| Reason/Issue |
Philips has detected a hardware problem with the vertical servo motor used in the bariatric couch of Incisive CT. If the couch is kept at its lowest position frequently in preparation for scanning, there is a potential that the vertical servo motor may be damaged and interrupt the vertical motion of the couch. A burning smell and a small amount of smoke may occur following the damage of the vertical servo motor.
Philips has received complaints, however, there are no reports of injury. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Philips will contact customers to schedule a time for a Field Service Engineer to correct this problem.
In the interim customers are to:
Limit keeping the couch at its lowest position when the system is powered up and not in use. If this issue occurs:
1)Remove patients and operators from the vicinity to limit exposure.
2) Contact a local Philips representative for further support.
Philips is advising the system can continue to be used in accordance with the intended use. |
| Contact Information |
1800 251 400 - Philips Service Delivery |