Philips Medical Systems is recalling several models of the Azurion 3, 5, and 7 Image Guided Therapy Systems with software versions R2.1.10 and R2.2.10. These specialized medical imaging systems, manufactured in the Netherlands, are being updated due to six identified software issues that can cause the system to restart unexpectedly or lose positional accuracy. Philips is providing a software correction to repair these errors and ensure the devices operate correctly during medical procedures.
Software defects may cause the system to enter a continuous restart loop, run out of memory space, or suffer from longitudinal positional errors and tool misalignment. These failures could lead to a loss of imaging or guidance during a critical procedure, potentially delaying treatment or causing surgical errors.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · Raw API Response
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