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Type of Product Medical Device
TGA Recall Reference RC-2013-RN-00423-1
Product Name/Description Brilliance CT 64, Ingenuity Core, Ingenuity Core 128 systems using software versions 2.6.1 or 3.5.4 (Computed tomography full-body x-ray system)

ARTG Number: 98868
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 9/05/2013
Responsible Entity Philips Electronics Australia Ltd
Reason/Issue Philips Healthcare received reports that certain Brilliance CT 64 Ingenuity Core systems running software versions 2.6.1 or 3.5.4 exhibited intermittent swirl-like ring artifacts that may appear on reconstructed images, which may impair the diagnostic quality of affected images.
Recall Action Recall for Product Correction
Recall Action Instructions Philips Healthcare is advising that clinical judgment should be used by the customer/user to determine if the images contained in the dataset without artifacts contain enough information to make a diagnosis. If these images are sufficient, no further action is required. If the images are not sufficient, a re-scan of the patient is required. Philips Healthcare is implementing software update versions 2.6.2 or 3.5.5 to permanently correct the issue. This action has been closed-out on 12/02/2016.
Contact Information 1800 251 400 - Philips Customer Care Centre