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Type of Product Medical Device
TGA Recall Reference RC-2015-RN-01163-1
Product Name/Description Ingenuity CT, Ingenuity Core, Ingenuity Core128, Brilliance 64, Brilliance iCT SP, Brilliance iCT systems with software versions 4.1.2, 4.1.3 and 4.1.4

ARTG Number: 98868
Recall Action Level Hospital
Recall Action Classification Class III
Recall Action Commencement Date 27/11/2015
Responsible Entity Philips Electronics Australia Ltd
Reason/Issue On the affected CT systems and software versions, the perfusion scan feature may be unavailable. No harm has been reported, and no potential harm because of unavailability of the scanner feature.
Recall Action Recall for Product Correction
Recall Action Instructions A software update will be released to correct the issue by Philips. A Philips Field Service Engineer will contact customers to schedule the software update installation at their site. This action has been closed-out on 04/07/2017.
Contact Information 1800 251 400 - Philips Customer Care Centre