FDA Device Intelligence
HomeDevice types › JAK

System, X-Ray, Tomography, Computed

FDA product code JAK · Class 2 · Radiology

1,267
Registered devices
5,242
Adverse events
865
Recalls
822
510(k) clearances

Devices with this code

Recent recalls

DateFirmReason
2026-08-07Philips North America LlcPhilips has identified an unintended radiation issue with the Philips IQon, iCT, Ingenuity, and Brilliance CT 64 systems that could affect the performance of th
2026-08-07Philips North America LlcPhilips has identified an unintended radiation issue with the Philips IQon, iCT, Ingenuity, and Brilliance CT 64 systems that could affect the performance of th
2026-08-07Philips North America LlcPhilips has identified an unintended radiation issue with the Philips IQon, iCT, Ingenuity, and Brilliance CT 64 systems that could affect the performance of th
2026-08-07Philips North America LlcPhilips has identified an unintended radiation issue with the Philips IQon, iCT, Ingenuity, and Brilliance CT 64 systems that could affect the performance of th
2026-06-26Philips Healthcare (Suzhou) Co., Ltd.Potential of failing to trigger clinical scan during Bolus Tracking.
2026-06-11PHILIPS MEDICAL SYSTEMSThe clinical CT scan may not automatically trigger after the Bolus Tracking scan and may need to be triggered manually. Additional Bolus Tracking shots may occu
2026-06-11PHILIPS MEDICAL SYSTEMSThe clinical CT scan may not automatically trigger after the Bolus Tracking scan and may need to be triggered manually. Additional Bolus Tracking shots may occu
2026-06-11PHILIPS MEDICAL SYSTEMSThe clinical CT scan may not automatically trigger after the Bolus Tracking scan and may need to be triggered manually. Additional Bolus Tracking shots may occu
2026-03-26GE Medical Systems, LLCGE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used
2026-03-26GE Medical Systems, LLCGE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.