FDA Device recall Z-2652-2026

Ingenuity CT CT5000 Ingenuity Plus CT5000 Ingenuity Pro CT5000 Ingenuity Premium Ingenuity CT Upgrades Ingenuity CT China Ingenuity Core 12…

• FDA Device
• Class II
• ongoing
• Published 2026-08-05

On 2026-08-05 the FDA classified a Class II recall of Ingenuity CT CT5000 Ingenuity Plus CT5000 Ingenuity Pro CT5000 Ingenuity Premium Ingenuity CT Upgrades Ingenuity CT China Ingenuity Core 12… by Philips Medical Systems, citing 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….

Read the official FDA Device notice

Product

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

Reason

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.

Identifiers

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.

Other recalls by Philips Medical Systems

• Spectral CT and Spectral CT 7500 RT
  FDA Device · Class II · 2026-10-14 · Philips Medical Systems
• IQon Spectral CT IQon Spectral CT Upgrades
  FDA Device · Class II · 2026-08-05 · Philips Medical Systems
• Brilliance iCT Brilliance iCT Upgrades Brilliance iCT SP Brilliance CT 64 Channel CT6000 Brilliance 64 Upgrades
  FDA Device · Class II · 2026-08-05 · Philips Medical Systems
• Philips Spectral CT on Rails
  FDA Device · Class II · 2026-04-22 · Philips Medical Systems
• Model: CT 5300
  FDA Device · Class II · 2025-11-05 · Philips Medical Systems

All Philips Medical Systems recalls

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2652-2026%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.