Print version of this report
TGA Action ID RC-2025-RN-00442-1
Type of Product Medical Device
Product Name/Description Philips Big Bore CT

Software Version: 4.8.0.10430

REF: 728243

Identifier: (01)00884838059450
ARTG Number 321687
Action Type Product Correction
Action Level Hospital
Hazard Classification Class II
Reason for the Action When releasing the motion button in touch panel of Interventional control (IVC) by sliding or dragging off the touch panel area, the motion button of vertical table motion and/or rocker tilt angle may not be released.
This problem could result in additional table up/down and/or Gantry tilt motion.

The Plan Box may not move to the desired Needle Position or Work Position under the following circumstances:
· Operator manually edits the Needle Position or Work Position value, and
· Operator moves Plan Box by dragging it or by changing its centre value and plan box position, and
· Operator uses Interventional Controls Move to Selected / Position buttons.

This problem could result in the table moving to a location the operator does not expect.

The additional Gantry or table motion could cause pain, abrasions, or lacerations, if not noticed and stopped by the operator.

If the table moves to a position that is not expected by the operator there is a risk that a scan may occur at an unintended location. A collision with the operator or with the needle placed inside the patient may also occur.
Instructions for Customers/Users Philips will contact customers to schedule a time for a Philips Field Service Engineer (FSE) to visit their site and install the solution to resolve the problem.

Customers may continue to use the system(s) in accordance with the intended use and by following the recommended actions in the Customer Letter.

Philips expects the correction to be released by July 2025.

This action has been closed out on 11/05/2026
Action Commencement Date 9/05/2025
Responsible Entity Philips Electronics Australia Ltd
Contact Information 1800 251 400 - Philips Service Delivery Team