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Type of Product Medical Device
TGA Recall Reference RC-2016-RN-00677-1
Product Name/Description DuraDiagnost X-ray systems with software version 3.0.3

ARTG Number: 207424
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 23/05/2016
Responsible Entity Philips Electronics Australia Ltd
Reason/Issue A firmware anomaly inside the detector (PX4343RG) can cause the detector to appear ready for acquisition on very short time intervals while it actually is not ready. This may result in an inadequate acquisition of the X-ray image. If a corrupted image cannot be used for its clinical purpose, it may be necessary to retake with additional exposure.
Recall Action Recall for Product Correction
Recall Action Instructions Philips is implementing a software upgrade to version 3.0.6 as a permanent correction. This action has been closed-out on 12/05/2017.
Contact Information 1800 251 400 - Philips Customer Care Centre