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Type of Product Medical Device
TGA Recall Reference RC-2016-RN-00595-1
Product Name/Description MobileDiagnost wDR 2, all software versions affected (diagnostic x-ray system)

All systems affected

ARTG Number: 187112
Recall Action Level Hospital
Recall Action Classification Class I
Recall Action Commencement Date 6/05/2016
Responsible Entity Philips Electronics Australia Ltd
Reason/Issue During recent evaluations of the Philips MobileDiagnost wDR 2, Philips has identified a potential issue that could result in unnecessary radiation exposure to the patient under certain conditions.

1. The system may sporadically apply the default x-ray exposure parameters for an adult (patient type: “Normal”), even though the patient type “Newborn” was selected and is displayed in the generator control area of the Eleva User Interface.

2. Under certain conditions, the detector might not be ready for examination. Released x-ray might lead to an image with artefacts and a retake is required. While the attachment process is running, the detector might be too short in front of the IR (Infrared) sensor and the problem of the washed out images can appear if an exposure is taken right after that.
Recall Action Recall for Product Correction
Recall Action Instructions Philips is providing work around instructions for users to follow as an interim measure. A software upgrade will be implemented as a permanent correction.
This action has been closed-out on 16/03/2018.
Contact Information 1800 251 400 - Philips Customer Care Centre