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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 Philips Electronics Australia Ltd
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