CLASS II ONGOING Device recall · Reported 5 Aug 2026 · FDA Enforcement Report
Ingenuity CT CT5000 Ingenuity Plus CT5000 Ingenuity Pro recalled
Philips Medical Systems is recalling Ingenuity CT CT5000 Ingenuity Plus CT5000 Ingenuity Pro CT5000 Ingenuity Premium, distributed nationwide in the US. The recall was initiated on 11 Jun 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2652-2026
- FDA event ID
- 99352
- Recalling firm
- Philips Medical Systems, Cambridge, MA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 11 Jun 2026
- FDA classified
- 27 Jul 2026
- Reported
- 5 Aug 2026
- Type
- FDA Mandated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 11 Jun 2026 | Recall initiated by company | |
| 27 Jul 2026 | Classified by FDA | +46 days |
| 5 Aug 2026 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Ingenuity CT CT5000 Ingenuity Plus CT5000 Ingenuity Pro CT5000 Ingenuity Premium Ingenuity CT Upgrades Ingenuity CT China Ingenuity Core 128 Elite Brazil
Where it was distributed
US Nationwide Distribution including Puerto Rico
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
FCO72800815, FCO72800816, 728321 DI (01)00884838059498 728323 DI (01)00884838059504 728326 DI (01)00884838059511 728327 DI (01)00884838098701 728324 DI (01)00884838059863 728325
Where was it sold?
US Nationwide Distribution including Puerto Rico
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 99352This product is part of a recall event; the main page for the event is IQon Spectral CT IQon Spectral CT Upgrades recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | IQon Spectral CT IQon Spectral CT Upgrades recalled | Philips Medical Systems | Device Malfunction | Nationwide | |
| CLASS II | Brilliance iCT Brilliance iCT Upgrades Brilliance iCT SP recalled | Philips Medical Systems | Device Malfunction | Nationwide |
More recalls from Philips Medical Systems
All 82| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Spectral CT and Spectral CT 7500 RT recalled by Philips Medical Systems | Philips Medical Systems | Device Malfunction | Nationwide |
| Device | CLASS II | Brilliance iCT Brilliance iCT Upgrades Brilliance iCT SP recalled | Philips Medical Systems | Device Malfunction | Nationwide |
| Device | CLASS II | IQon Spectral CT IQon Spectral CT Upgrades recalled | Philips Medical Systems | Device Malfunction | Nationwide |
| Device | CLASS II | Philips Spectral CT on Rails recalled by Philips Medical Systems | Philips Medical Systems | Device Malfunction | Nationwide |
| Device | CLASS II | Model: Incisive CT; Product Code (REF): (1) 728143, (2) recalled | Philips Medical Systems | Device Malfunction | 18 states |
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| Device | CLASS III | BeneView Series recalled by Mindray DS USA | Mindray DS USA | Device Malfunction | Nationwide |