| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2022-RN-01102-1 |
| Product Name/Description |
Philips SmartPath to dStream and Ingenia systems
Product code : 781341, 781396, 781261, 781262, 781260, 781271, 781342, 781377, 781347 and 781270
Multiple serial numbers
ARTG : 230064
(Philips Electronics Australia Ltd - MRI system, full-body, superconducting magnet) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
17/08/2022 |
| Responsible Entity |
|
| Reason/Issue |
Philips has identified an issue with the tabletop docking interface used for SmartPath to dStream and Ingenia systems. The purpose of the tabletop is to carry the patient during patient preparation and scanning. This issue is related to a potential instability of the tabletop when locked on the FlexTrak trolley.
The SmartPath to dStream and Ingenia system tabletops have a docking interface, which is located underneath the tabletop and attached with screws.
The screws fixating the tabletop docking interface may come loose, potentially leading to disengagement or some instability of the tabletop when clamped on the FlexTrak Trolley. Philips has confirmed that this potential issue impacts systems manufactured prior to May 2016.
There have been no adverse events reported to Philips as of June 2022. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Philips is advising customers to confirm the tabletop is locked securely per the Instructions for Use (IFU), related to the usage of the FlexTrak transportation system and trolley.
If instability of the tabletop is evident, it can be an indication that the screws have come loose. In this case, customers should stop using the FlexTrak trolley, and contact your local Philips Service representative.
Philips Service will contact all impacted customers to arrange a visit by a Field Service Engineer to check each MR system and correct the devices. This will be planned via Field Change Order FCO78100553. |
| Contact Information |
1800 251 400 - Philips Service Delivery Team |