OFFICIAL-SOURCE RECALL · AUSTRALIA
Incisive CT and CT 5300 with software version 5.1.2.X Recall: Classification Class II Reason for the Action
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- Incisive CT and CT 5300 with software version 5.1.2.X
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Why this product was recalled
Classification Class II Reason for the Action Philips has identified multiple software problems in software version 5.1.2.X affecting Philips Incisive CT and CT 5300 systems. These problems may affect system performance and result in image reconstruction failures, image artefacts, scan failures, incomplete image sets, delayed visual breath-hold guidance, incorrect voice prompt settings, or inaccurate positioning guidance during CT-guided procedures. Philips has not received any reports of harm or injuries associated with these problems as of June 2026. Instructions for Customers/Users - Customers may continue to use the system(s) in accordance with the intended use. - Philips will
Hazard
Classification Class II Reason for the Action Philips has identified multiple software problems in software version 5.1.2.X affecting Philips Incisive CT and CT 5300 systems. These problems may affect system performance and result in image reconstruction failures, image artefacts, scan failures, incomplete image sets, delayed visual breath-hold guidance, incorrect voice prompt settings, or inaccurate positioning guidance during CT-guided procedures. Philips has not received any reports of harm or injuries associated with these problems as of June 2026. Instructions for Customers/Users - Customers may continue to use the system(s) in accordance with the intended use. - Philips will
Official recall notice
Incisive CT and CT 5300 with software version 5.1.2.X
Agency: Therapeutic Goods Administration
Official publication date: August 14, 2026
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