CLASS II ONGOING Device recall · Reported 5 Aug 2026 · FDA Enforcement Report
Brilliance iCT Brilliance iCT Upgrades Brilliance iCT SP recalled
Philips Medical Systems is recalling Brilliance iCT Brilliance iCT Upgrades Brilliance iCT SP Brilliance CT 64 Channel CT6000, 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-2650-2026
- 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
Brilliance iCT Brilliance iCT Upgrades Brilliance iCT SP Brilliance CT 64 Channel CT6000 Brilliance 64 Upgrades
Where it was distributed
US Nationwide Distribution including Puerto Rico
Stores named: Walmart
Questions about this recall
Is Brilliance iCT Brilliance iCT Upgrades Brilliance iCT SP Brilliance CT 64 Channel CT6000 recalled?
Yes. Philips Medical Systems recalled Brilliance iCT Brilliance iCT Upgrades Brilliance iCT SP Brilliance CT 64 Channel CT6000 on 11 Jun 2026. The recall is Class II and its status is Ongoing. Recall number Z-2650-2026.
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?
FCO72800812; FCO72800814 728305 728306 DI (01)00884838059474 728307 DI (01)00884838104600 728311 728231 (01)00884838083325 728232
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Philips Medical Systems
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|---|---|---|---|---|---|
| Device | CLASS II | Ingenuity CT CT5000 Ingenuity Plus CT5000 Ingenuity Pro 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 | Lead & Heavy Metals | Nationwide |
| Device | CLASS II | Model: CT 5300; Product Code (REF): 728285; Software Versions recalled | Philips Medical Systems | Lead & Heavy Metals | Nationwide |
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