Agency classClass IIOur severity:High FDA (Devices)·Z-2652-2026·Announced 2026-08-05

Philips Ingenuity CT Scanners Recalled Due to Bolus Tracking Trigger Issue

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.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall with no reported injuries; the device malfunction poses a risk of inadequate diagnosis and additional radiation, matching the High rubric criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Philips Medical Systems is recalling 182 Ingenuity CT systems distributed nationwide in the United States, including Puerto Rico. Affected products include the CT5000 Ingenuity Plus, CT5000 Ingenuity Pro, CT5000 Ingenuity Premium, Ingenuity CT Upgrades, Ingenuity CT China, and Ingenuity Core 128 Elite Brazil.

The recall is due to an issue in which the clinical CT scan may not automatically trigger after a Bolus Tracking scan and may need to be triggered manually. Additional Bolus Tracking shots may also occur. This could make the clinical acquisition inadequate for diagnosis, potentially requiring the patient to be rescanned and exposed to additional radiation.

The FDA has classified this recall as Class II. The recall notice does not report any injuries or deaths and does not provide specific consumer instructions.

The recalled product

Product: Ingenuity CT CT5000 Ingenuity Plus CT5000 Ingenuity Pro CT5000 Ingenuity Premium Ingenuity CT Upgrades Ingenuity CT China Ingenuity Core 128 Elite Brazil
Manufacturer: PHILIPS MEDICAL SYSTEMS
Category: Medical Device — CT Imaging System
Hazard: device-malfunction
radiation-exposure
inadequate-diagnosis
Affected units: 182

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

FCO72800815
FCO72800816

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 3 recalled by PHILIPS MEDICAL SYSTEMS under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Same manufacturer · PHILIPS MEDICAL SYSTEMS

See all →

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Philips CT Scanners Recalled Due to Bolus Tracking Trigger Issue
FDA (Devices) · 2026-08-05
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Philips Spectral CT on Rails recalled over three software issues
FDA (Devices) · 2026-04-22
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CT scanners recalled over six software faults affecting movement and dose
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Same hazard · device malfunction