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Type of Product Medical Device
TGA Recall Reference RC-2016-RN-01595-1
Product Name/Description Philips Ingenia 1.5T and Ingenia 3.0T MR systems with Ingenia MR-OR solution

ARTG Number: 230064
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 12/12/2016
Responsible Entity Philips Electronics Australia Ltd
Reason/Issue There is an electrical component called MR-OR Laser control board in the FlexTrak OR trolley, under the Interface Adapter. In production, two MR-OR Laser control boards have been found where the Laser control board has been assembled incorrectly, leading to insufficient isolation distance. Hence, there is a possibility that a patient or user may be exposed to a very small, level of touch current. In practice, the current is so low that it may not even be noticed.
Recall Action Recall for Product Correction
Recall Action Instructions Philips has revised the design of the control board and is sending out service engineers to install the revised boards.
This action has been closed-out on 23/03/2018.
Contact Information 1800 251 400 - Philips Customer Care Centre