FDA (Devices) recall action 99352
The FDA (Devices) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.
The clinical CT scan may not automatically trigger after the Bolus Tracking scan and may need to be triggered manually. Additional Bolus Tracking shots may occur. This may result in the clinical acquisition being inadequate for diagnosis, causing a potential for patient rescan and receiving additional radiation.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Philips is recalling IQon Spectral CT systems because the clinical scan may not start automatically after Bolus Tracking, requiring manual triggering and potentially causing extra radiation exposure.
Philips is recalling certain CT scanners because the clinical scan may not start automatically after Bolus Tracking, which could require a patient rescan and expose them to additional radiation.
Philips is recalling 182 Ingenuity CT systems in the US because the clinical scan may not trigger automatically after Bolus Tracking, potentially causing patient rescan and extra radiation.