| 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 |
|
| 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 |