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Type of Product Medical Device
TGA Recall Reference RC-2013-RN-00470-1
Product Name/Description MammoDiagnost DR with software release 2.1 (mammography system)

ARTG number: 117662
Recall Action Level Hospital
Recall Action Classification Class III
Recall Action Commencement Date 24/05/2013
Responsible Entity Philips Electronics Australia Ltd
Reason/Issue The dose exceeds levels set by local regulations in Sweden, New Zealand and Australia when Automatic Exposure Control (AEC) is used and the exposure time in magnification mode is too long.
Recall Action Recall for Product Correction
Recall Action Instructions End users are informed that the system can continue to be used according to the instructions for use. New software will be implemented to ensure compliance with local requirements.
Contact Information 1800 251 400 - Philips Customer Care Centre