| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2023-RN-00582-1 |
| Product Name/Description |
Philips Spectral CT 7500
Product codes: 728333 and 728340
Device Identifiers: 00884838101111 and 00884838111103
Serial numbers: 396001, 396003, 397002, 397007 and between 10013 to 10135
ARTG 321687
(Philips Electronics Australia Ltd - X-ray system, diagnostic, computed tomography, full-body) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
28/06/2023 |
| Responsible Entity |
|
| Reason/Issue |
The Technical Reference Guide for Spectral CT states that examination room temperature must be between 18° to 24°C (64° to 75°F). Philips has identified an issue where a scan could be interrupted with one of the below error messages when the room temperature is at the high end of the temperature rang. If this issue occurs, all patient scan data prior to the shutdown can be restored. In some situations, a rescan may be needed which would be a repeat of the surview or bolus tracking scans. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Philips will contact you to schedule a time for a Philips Field Service Engineer (FSE) to visit your site and install the solution to resolve this issue (reference FCO72800799).
This action has been closed out on 18/04/2024 |
| Contact Information |
1800 251 400 - Philips Service Delivery Team |