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Type of Product Medical Device
TGA Recall Reference RC-2017-RN-01454-1
Product Name/Description Brilliance iCT (Model 728306), Brilliance iCT SP (Model 728311) and IQon Spectral CT (Model 728332) Scanner systems

Manufactured beginning May 2009

ARTG: 98868
Recall Action Level Hospital
Recall Action Classification Class III
Recall Action Commencement Date 4/12/2017
Responsible Entity Philips Electronics Australia Ltd
Reason/Issue There is a possibility that screws holding an internal portion of the gantry (Reaction Ring) to the scanner’s main bearing may come loose. If this occurs, the part(s) will not be expelled, however, a noise may be heard coming from the gantry. There is no potential for harm to the patient or operator due to this issue.
Recall Action Recall for Product Correction
Recall Action Instructions Philips is advising users that they will be inspecting the affected systems, tightening and replacing the reaction ring screws as needed at no additional cost. (Reference: Field Correction FCO 72800690)

This action has been closed out on 24/10/2019

This action has been closed out on 24/10/2019
Contact Information 1800 251 400 - Philips Customer Care