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Medical devices safety
The safety and performance of medical devices is continuously monitored. Approved devices must continue to meet all the requirements of their approval.
Latest alerts
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Boston Scientific have advised that subsets of ACCOLADE and VISIONIST pacemakers have an increased risk of permanently entering Safety Mode which has limited functionality.
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There is a potential for insulin leakage with the Accu-Chek Spirit 3.15 ml cartridge system due to a manufacturing problem.
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Insulet is advising they have received complaints of Omnipod DASH PDM/controller battery depletion as a result of the 3G network deactivation in the region.
Latest articles
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Recall reforms update and new procedure
Recall reforms program update and preview of the PRAC Version 1.0. -
Medical devices affected by the 3G network shutdown
The 3G network shutdown may impact certain medical devices. Consumers, healthcare providers, manufacturers, and suppliers should take precautions to prevent disruption in essential medical services. -
Our response to questions asked about the Essential Principles consultation
Following our Essential Principles presentations on 11-12 September 2024, we have collated questions asked into themes to simplify finding information of relevance to you.
Latest publications
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Read key points of discussion from the meeting 14 of the Medical Devices Consumer Working Group (MDCWG).
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Read key points of discussion from the meeting 13 of the Medical Devices Consumer Working Group (MDCWG).
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The TGA is working with the Australian Commission on Safety and Quality in Health Care and Australian hospitals, peak bodies, and state, and territory governments to improve and increase rapid information sharing about medical device safety and effectiveness