Print version of this report
Type of Product Medical Device
TGA Recall Reference RC-2018-RN-00739-1
Product Name/Description MobileDiagnost wDR

Model Number: 712002

ARTG Number: 187112
(Philips Electronics Australia - X-ray system, diagnostic, general-purpose, mobile, digital)
Recall Action Level Hospital
Recall Action Classification Class III
Recall Action Commencement Date 14/06/2018
Responsible Entity Philips Electronics Australia Ltd
Reason/Issue Philips have identified that when the operator or a bystander touches the area of the inner part of the vertical sliding column (on which the tube arm moves up or down), without paying attention of the tube arm movement, the operator's fingers can be pinched.
Recall Action Product Defect Correction
Recall Action Instructions Philips are advising that they will install a new label on affected systems. A Philips Service Engineer will contact customers when the Field Action Kit is available to be implemented.

In the interim, customers may continue to use their systems, provided they follow the Instructions for Use which outlines that users keep all body parts and clothing free of the equipment to avoid getting caught or trapped within the moving components.

This action has been closed out on 16/07/2019
Contact Information 1800 251 400 - Philips Customer Care