| TGA Action ID |
RC-2025-RN-00670-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Philips IntelliSite Pathology Solution (PIPS) 3.x and 5.x (software versions IMS 3.x and IMS 4.x). An in vitro diagnostic medical device (IVD)
Product codes: 760001, 760042, 760045 |
| ARTG Number |
335889, 384705 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class III |
| Reason for the Action |
The problem is that the free space is incorrectly calculated for IMS configured with primary storage and additional storage.
In that scenario, the total free space percentage of primary storage AND additional storage is calculated. The image data received from the scanner is initially stored on the primary storage. Additional storage is a second storage location that has no function to receive image data directly from the scanner.
This free space problem applies to IMS 4.x and IMS 3.x.
When there is not sufficient free space on the primary storage, no new image data from the scanners can be added. |
| Instructions for Customers/Users |
Customers may continue to use their system(s) in accordance with the intended use and should ensure data cleanup is done on the primary disk regularly as stated in Attachment within the customer letter and the Instructions for Use (IFU).
Philips will be contacting customers to schedule a remote installation of new software which is available now to address the free-space notification problem.
This action has been closed out on 23/06/2026 |
| Action Commencement Date |
5/08/2025 |
| Responsible Entity |
|
| Contact Information |
1800 251 400 - Philips Service Delivery Team |