Philips Healthcare is recalling 140 Incisive CT systems running software version 5.0 due to three distinct software defects. These issues can cause heart scans to trigger at the wrong time, lead to scans occurring in the wrong location on the body when a scan is aborted and restarted, or cause deviations in scan areas for bariatric patients using the specialized 'Noah' couch. These software failures may result in inaccurate diagnostic images or unnecessary radiation exposure to patients. Philips initiated this recall via a notification letter to affected healthcare facilities in August 2023.
The software defects can cause the CT scanner to deviate from the intended imaging area or timing, which may lead to diagnostic errors, the need for repeat scans, or unintended radiation exposure to healthy tissue. Patients undergoing heart scans or bariatric procedures are at specific risk of the device not performing as clinically intended.
Manufacturer Notification and Software Correction
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.
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Sources: FDA iRES · Raw API Response
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