Recall Z-2652-2026
- Recall number
- Z-2652-2026
- Event number
- 99352
- Firm
- PHILIPS MEDICAL SYSTEMS
- Firm FEI
- 3017726341
- Product code
- JAK
- Status
- Open, Classified
- Initiated
- 2026-06-11
- Posted
- 2026-07-27
- Root cause
- Radiation Control for Health and Safety Act
- 510(k) numbers
- K160743, K993645, K253173, K233767, K242874, K023785, K171677, K151833, K102102, K212875, K181646, K090220, K082458, K790395, K861708, K032243, K944326, K203187, K233753, K153004, K182716, K232412, K073138, K780115, K052587, K010817, K911764, K232227, K201586, K142955
Product#
Ingenuity CT CT5000 Ingenuity Plus CT5000 Ingenuity Pro CT5000 Ingenuity Premium Ingenuity CT Upgrades Ingenuity CT China Ingenuity Core 128 Elite Brazil
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.