| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2023-RN-01012-1 |
| Product Name/Description |
Achieva 1.5T MRI System
Product: 781296
Serial Numbers: 32306 and 33117
ARTG 230064
(Philips Electronics Australia Ltd - MRI system, full-body, superconducting magnet) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
22/11/2023 |
| Responsible Entity |
|
| Reason/Issue |
Philips has identified an issue with certain models of its 1.5T MR systems, the Achieva 1.5T, Achieva 1.5T Conversion, Ingenia 1.5T CX, Intera 1.5T, Intera 1.5T Power/Pulsar, and SmartPath to dStream for 1.5T systems (“Affected 1.5T MR Systems”), that could pose a risk for patients and/or users.
A specific component failure in the Gradient Coil of the affected 1.5T MR Systems may act as a heat source with a potential to produce smoke and/or fire. If the component failure occurs, the user may observe the following:
· Repeated scan abort error messages due to gradient amplifier fault detection
· Unusual noise from the system in the examination or technical room
· Smoke and/or fire from within the system |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Customers should
1. Identify if their device is affected based on the listed serial numbers.
2. Follow the instructions provided in section 4 of the customer letter.
3. Post the Appendix B – Actions for Customer / User: provided the customer letter near the affected MR unit for ease of reference.
NB: Philips continues to investigate the root cause of this issue and anticipate providing an update to the possible mitigations required in early 2024. |
| Contact Information |
1800 251 400 - Philips Service Delivery Team |