| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-01389-1 |
| Product Name/Description |
Achieva 3.0T and Ingenia 3.0T MR Systems with passive shielding in the rear wall
ARTG Number: 98887 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
24/10/2016 |
| Responsible Entity |
|
| Reason/Issue |
For the Achieva 3.0T and Ingenia 3.0T MR systems on sites with rear wall passive shielding, the thickness and location of shielding material must be installed according to requirements provided by Philips. In cases where the requirements are not followed, the distance between the passive shielding rear wall and magnet could be insufficient. An insufficient distance leads to stronger attraction forces between the magnet and the passive shielding, which may lead to shearing of the magnet vibration pads. In a worst case scenario there may be displacement of the magnet, which could possibly result in harm (crushing risk) to persons inside the MR room and located between the magnet and passive shielding wall. To date there has been one overseas report of the magnet shifting with no harm to users or patients. Displacement of a magnet can also result in image quality issues and mechanical fitting problems with the table. These functional issues affect the clinical usage of the MR system. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Philips is advising customers that if the distance between magnet covers and finished rear wall is less than 1.3m, to contact Philips. In addition, Philips Field Service Engineers will be visiting all sites and checking this distance. If action is required, Philips will, as appropriate, replace the magnetic vibration pads and/or install seismic brackets. Depending on the circumstances, it may be advised that further clinical use of the MR system should not occur until after the installation corrections have been completed.
This action has been closed out on the 12/11/2018. |
| Contact Information |
1800 251 400 - Philips Customer Care Centre |