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Type of Product Medical Device
TGA Recall Reference RC-2018-RN-00312-1
Product Name/Description Philips Ingenuity Core (728321)

Serial Numbers: 333166, 333170, 333171, 333173-333181, 333184

ARTG Number: 98868
(Philips Electronics Australia - X-ray system, diagnostic, computed tomography, full-body)
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 12/04/2018
Responsible Entity Philips Electronics Australia Ltd
Reason/Issue Philips has identified systems that may have been infected with the "Wannacry" ransomware virus before installation. The virus may encrypt files in a way that:
- prevents system access; or
- a patient undergoing a scan or recently scanned whose results have not been reviewed may require a CT rescan; or
- during a biopsy the system may be slowed such that the operator is unable to visualise the advancement of a biopsy needle in real time
To date, there have been no reports of patient harm as a result of this issue.
Recall Action Product Defect Correction
Recall Action Instructions Philips are advising that they will be contacting users to arrange an appointment for a Field Service Engineer to correct the software on any potentially impacted systems

This action has been closed out on 19/02/2019
Contact Information 1800 251 400 - Customer Service Support