System, X-ray, Tomography, Computed
Radiology · 21 CFR 892.1750
Recent MDR events
5,243 adverse event reports on file
- ILLUMISITEJul 31, 2026MalfunctionCovidien Lp - Superdimension Inc3004962788-2026-00064
- SOMATOM ForceJul 30, 2026MalfunctionSiemens Healthineers Ag3004977335-2026-00127
- NL3000Jul 27, 2026MalfunctionSamsung Hme America, Inc.3004938766-2026-00036
- SOMATOM Edge PlusJul 27, 2026MalfunctionSiemens Healthineers Ag3004977335-2026-00123
- SOMATOM go.TopJul 27, 2026MalfunctionSiemens Healthineers Ag3004977335-2026-00124
- SOMATOM DriveJul 27, 2026MalfunctionSiemens Healthineers Ag3004977335-2026-00125
- ILLUMISITEJul 20, 2026MalfunctionCovidien Lp - Superdimension Inc3004962788-2026-00063
- SOMATOM DEFINITION FLASHJul 17, 2026InjurySiemens Healthineers Ag3004977335-2026-00121
- ILLUMISITEJul 16, 2026InjuryCovidien Lp - Superdimension Inc3004962788-2026-00060
- UNKNOWN INTERV. LUNG SOLUTIONS PRODUCTJul 16, 2026InjuryCovidien Lp - Superdimension Inc3004962788-2026-00061
Event type breakdown
Recalls
860 recall events for this product code
- PHILIPS MEDICAL SYSTEMSOpen, ClassifiedJul 27, 2026
Brilliance iCT
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.
Z-2650-2026 · View FDA record ↗ - PHILIPS MEDICAL SYSTEMSOpen, ClassifiedJul 27, 2026
IQon Spectral CT
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.
Z-2651-2026 · View FDA record ↗ - PHILIPS MEDICAL SYSTEMSOpen, ClassifiedJul 27, 2026
Ingenuity CT
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.
Z-2652-2026 · View FDA record ↗ - GE Medical Systems, LLCOpen, ClassifiedMay 8, 2026
Revolution Ascend, computed tomography, Model Numbers 6969000-100 and 6969000-300
GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used in conjunction with certain Revolution Apex, Revolution Ascend, and Revolution CT systems.
Z-2149-2026 · View FDA record ↗ - GE Medical Systems, LLCOpen, ClassifiedMay 8, 2026
Revolution CT, x-ray computed tomography, Model Numbers 5590000 and 5590000-6
GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used in conjunction with certain Revolution Apex, Revolution Ascend, and Revolution CT systems.
Z-2150-2026 · View FDA record ↗ - GE Medical Systems, LLCOpen, ClassifiedMay 8, 2026
Revolution Apex Elite, X-ray Computed Tomography, Model Number 5590000-23
GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used in conjunction with certain Revolution Apex, Revolution Ascend, and Revolution CT systems.
Z-2151-2026 · View FDA record ↗ - GE Medical Systems, LLCOpen, ClassifiedMay 8, 2026
Revolution Apex Plus, X-ray Computed Tomography, Model Number 5590000-25
GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used in conjunction with certain Revolution Apex, Revolution Ascend, and Revolution CT systems.
Z-2152-2026 · View FDA record ↗ - GE Medical Systems, LLCOpen, ClassifiedMay 8, 2026
Revolution CT ES, X-ray Computed Tomography, Model Number 5590000-15
GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used in conjunction with certain Revolution Apex, Revolution Ascend, and Revolution CT systems.
Z-2153-2026 · View FDA record ↗ - GE Medical Systems, LLCOpen, ClassifiedMay 8, 2026
Revolution Apex, X-ray Computed Tomography, Model Number 5590000-20
GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used in conjunction with certain Revolution Apex, Revolution Ascend, and Revolution CT systems.
Z-2154-2026 · View FDA record ↗ - GE Medical Systems, LLCOpen, ClassifiedMay 8, 2026
Revolution Apex Select, X-ray Computed Tomography, Model Number 5590000-27
GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used in conjunction with certain Revolution Apex, Revolution Ascend, and Revolution CT systems.
Z-2155-2026 · View FDA record ↗
Registered firms
1,224 firms currently registered for this product code
Ge Medical Systems Israel, Functional Imaging
Haifa, IL
Aidoc Medical Ltd.
Tel Aviv-Yafo, IL
Gexpro, A Division Of Rexel Usa, Inc.
Menomonee Falls, WI, US
Siemens Healthineers Ag
FORCHHEIM Bavaria, DE
Ge Medical Systems Israel, Functional Imaging
Haifa, IL
Probo Medical Sas
NANTES Loire-Atlantique, FR
Ge Medical Systems Scs
BUC, FR
Ge Medical Systems Israel, Functional Imaging
TIRAT HACARMEL Haifa, IL
Ge Hangwei Medical Systems Co., Ltd.
Beijing, CN
Canon Inc.
OHTA-KU Tokyo, JP
Philips Medical Systems Nederland B.v.
Best Noord-Brabant, NL
Metropolis International, Llc
Long Island City, NY, US
Can Technomed Trading Ltd.
Richmond British Columbia, CA
Arineta Ltd.
Caesarea Industrial Zone Northern, IL
Block Imaging Parts & Service
Holt, MI, US
Auris Health, Inc
Santa Clara, CA, US
Omnilifescience, Inc.
Raynham, MA, US
Elekta Solutions Ab
STOCKHOLM, SE
Cis Computerised Imaging Services Pty Ltd
Bondi Junction New South Wales, AU
510(k) clearances
822 clearances for this product code
- NeuroLogica Corp., a Samsung CompanyJul 28, 2026
K253450 · BodyTom Elite (NL4000)
- GE Medical Systems SCSJul 21, 2026
K253770 · CardIQ Suite
- Ge Medical Systems, LLCJun 24, 2026
K253560 · Enhanced Boundary for PCCT
- Varian Medical Systems, Inc.Jun 4, 2026
K253026 · Respiratory Gating for Scanners (2.1)
- Canon Medical Systems CorporationMay 20, 2026
K253596 · Aquilion ONE (TSX-308A/TSX-306A) V2.0
- Philips Medical Systems Technologies , Ltd.Mar 27, 2026
K253649 · Spectral CT Verida Family
- Ge Healthcare Japan CorporationMar 23, 2026
K253686 · True Definition DL
- Philips Healthcare (Suzhou) Co., Ltd.Mar 23, 2026
K252992 · CT Rembra RT; CT Areta RT; CT Rembra