| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00577-1 |
| Product Name/Description |
Ingenia, Intera and Achieva MR Systems on software version R5.1.1 and R5.1.2
ARTG Number: 98887 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
22/05/2014 |
| Responsible Entity |
|
| Reason/Issue |
The problem can occur when the field of view of the clinical stations is below (more towards the feet) the light visor position. In such a situation an error is made in calculating the position information. This causes incorrect positioning of cross-reference lines on fused sagittal images.The cross reference lines of transversal images are displayed in an incorrect position on a fused image which has been generated through MobiView post processing. The cross reference lines are correctly displayed on the unfused stations.
|
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Philips is advising end users to not perform planning or review planning of transversal images on fused sagittal images which were generated through MobiView post-processing. Philips field service engineers will disable the MobiView post processing software until a software update has been developed and distributed. This action has been closed-out on 12/02/2016. |
| Contact Information |
1800 251 400 - Philips Customer Care Centre |