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FDA
Food and Drug Administration · Recall Z-2652-2026 · Jun 11, 2026

Ingenuity CT CT5000 Ingenuity Plus CT5000 Ingenuity Pro CT5000 Ingenuity Premium Ingenuity CT Upgrades Ingenuity CT China Ingenuity Core 128 Elite Brazil

PHILIPS MEDICAL SYSTEMS

The hazard

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. FDA Class II recall.

The remedy

Follow FDA guidance

About this recall

Ingenuity CT CT5000 Ingenuity Plus CT5000 Ingenuity Pro CT5000 Ingenuity Premium Ingenuity CT Upgrades Ingenuity CT China Ingenuity Core 128 Elite Brazil

Affected identifiers

Check these against the label on your unit. An identifier match is how a recall is confirmed, not just suspected.

Model FCO72800815Model FCO72800816UPC 00884838059498UPC 00884838059504UPC 00884838059511UPC 00884838098701UPC 00884838059863

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Sourced from the Food and Drug Administration’s public recall data. Always verify serial and date ranges against the official notice before acting.