| TGA Action ID |
RC-2026-RN-00777-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Philips Radiography 7000 M system
Model Number: 712010 |
| ARTG Number |
451166 |
| Unique Device Identifier (UDI) |
N/A |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
A problem may occur with the Radiography 7000 M system immediately after an exposure, causing the drive function to fail and preventing repositioning of the system. The system may remain stationary instead of driving upon activation of the handlebar. The problem is intermittent and has been observed during routine mobile radiography use.
The inability to reposition the system after exposure may result in delayed access to a patient and potential delay to treatment or therapy.
As of July 2026, Philips has received 35 complaints associated with this problem. There has been one (1) report where the no-drive condition impeded active patient resuscitation during emergency use. |
| Instructions for Customers/Users |
If the no-drive problem occurs and prevents repositioning of the system, customers are to:
· Restore system movement through one or more of the methods described in section 4 of the customer letter.
Philips will be implementing a software correction to address the problem. The release of the software correction is planned for Q1 2027. A Philips representative will contact customers to schedule implementation when the correction becomes available. |
| Action Commencement Date |
6/10/2026 |
| Responsible Entity |
|
| Contact Information |
1800 251 400 - Philips Service Delivery Team |