| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2023-RN-00678-1 |
| Product Name/Description |
Philips Spectral CT7500
Product code: 728333
Device identifier: 00884838101111
Serial numbers: 396001, 396003 and from serial number 10014 through serial number 10127
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 |
25/07/2023 |
| Responsible Entity |
|
| Reason/Issue |
For any scan type, if the Auto Voice and Breathing Lights buttons on the All Parameters tab are selected, it is possible that the automatic breathing instructions given by the system will be mismatched. The audio instructions to “Breath-In” are given by the system, but the “Breath-Out” Light Emitting Diode (LED) will light up. The “Breath-Out” audio instructions are also reversed with the “Breath-In” LED. The mismatch between the audio and visual breathing instructions may lead to patient confusion potentially resulting in a patient rescan being required. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Philips will contact customers to schedule a time for a Field Service Engineer to install the solution to resolve the issue.
In the meantime, customers are to deselect the Auto Voice and Breathing Lights buttons in All Parameters tab for the selected scan and provide the correct breathing instructions manually. The Plan Window and Parameters chapter in section 4 of the IFU has additional information.
This action has been closed out on 15/02/2024 |
| Contact Information |
1800 251 400 - Philips Service Delivery Team |