System, Image Processing, Radiological
Radiology · 21 CFR 892.2050
Recent MDR events
19,647 adverse event reports on file
- IntelliSpace CardiovascularJul 31, 2026MalfunctionPhilips Medical Systems Nederland B.v.3003768277-2026-101290
- System, Image Processing, RadiologicalJul 31, 2026MalfunctionBoston Scientific Corporation2124215-2026-41258
- IntelliSpace CardiovascularJul 30, 2026MalfunctionPhilips Medical Systems Nederland B.v.3003768277-2026-101283
- IntelliSpace CardiovascularJul 30, 2026MalfunctionPhilips Medical Systems Nederland B.v.3003768277-2026-101284
- IntelliSpace CardiovascularJul 30, 2026MalfunctionPhilips Medical Systems Nederland B.v.3003768277-2026-101285
- IntelliSpace CardiovascularJul 30, 2026MalfunctionPhilips Medical Systems Nederland B.v.3003768277-2026-101286
- Vue PACSJul 30, 2026InjuryPhilips Medical Systems Nederland B.v.3003768277-2026-101287
- IntelliSpace CardiovascularJul 30, 2026MalfunctionPhilips Medical Systems Nederland B.v.3003768277-2026-101288
- IntelliSpace CardiovascularJul 29, 2026MalfunctionPhilips Medical Systems Nederland B.v.3003768277-2026-101274
- IntelliSpace CardiovascularJul 29, 2026MalfunctionPhilips Medical Systems Nederland B.v.3003768277-2026-101275
Event type breakdown
Recalls
552 recall events for this product code
- Merge Healthcare, Inc.Open, ClassifiedAug 4, 2026
Merge PACS, medical imaging diagnostic workstation
Merge Healthcare has identified a potential issue that may cause thumbnails from a previously opened patient study to be displayed in the Thumbnail Bar while a different patient study is open.
Z-2874-2026 · View FDA record ↗ - Merge Healthcare, Inc.Open, ClassifiedAug 4, 2026
Merge OrthoPACS, medical imaging diagnostic workstation
Merge Healthcare has identified a potential issue that may cause thumbnails from a previously opened patient study to be displayed in the Thumbnail Bar while a different patient study is open.
Z-2875-2026 · View FDA record ↗ - Boston Scientific CorporationOpen, ClassifiedJul 22, 2026
Boston Scientific TheraSphere 360 Y-90 Management Platform, Model Number M00139509001; Radiological Image Processing System.
Software anomaly occurs when a user adds one or more vials to the cart and subsequently returns to the Activity Calculator to modify one or more input. When a user modifies an input and selects "Recalculate", the dose calculation is updated correctly; however, any vials that were previously added to the cart are not automatically updated to reflect the revised calculation.
Z-2771-2026 · View FDA record ↗ - GE Medical Systems SCSOpen, ClassifiedJun 24, 2026
GE Healthcare AW Server 3.2 ext.6.5; Radiological Image Processing System
GE HealthCare has become aware of a context synchronization issue in AW Server 3.2 ext. 6.5. When a user selects a patient or exam in the AW Server Web Client worklist and launches an interactive application (e.g. Volume Viewer), the application may open the previous patient's exam instead of the intended one. When this issue occurs, there is no system warning or error notification. If the error is not recognized, a clinical user could review, interpret, or report images for the wrong patient which could lead to misdiagnosis, incorrect clinical decisions, resulting in delayed or incorrect treatment.
Z-2553-2026 · View FDA record ↗ - Mint Medical GmbHOpen, ClassifiedMay 6, 2026
Mint Lesion;
If the connection between a mint Lesion workstation and the mint Lesion server is interrupted while performing a read, in rare cases some information may be lost or incorrectly linked to other patients.
Z-2068-2026 · View FDA record ↗ - PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Open, ClassifiedApr 10, 2026
Philips AneurysmFlow. Model Number: 001015.
Potential safety issue involving the Mean Aneurysm Flow Amplitude (MAFA) ratio of AneurysmFlow (Interventional Tool). Philips has determined that the MAFA ratio does not provide reliable prognostic information regarding aneurysm occlusion following Flow Diverter Stent treatment, however despite being stated in the IUF, it is being relied on for making clinical decisions.
Z-1805-2026 · View FDA record ↗ - PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Open, ClassifiedMar 27, 2026
Vue Motion V12. Product Number: 1017979.
Potential that mis-ordered frames in Vue Motion during dynamic cine runs may cause images frames to display out of sequence.
Z-1692-2026 · View FDA record ↗ - GE Medical Systems, LLCOpen, ClassifiedMar 16, 2026
Centricity Universal Viewer Software Versions 7.0 through 7.0 Sp2.0.1, a device that displays medical images (including mammograms) and data from various imagin
There is a potential cybersecurity vulnerability affecting certain versions of Centricity Universal Viewer. User login credentials may be exposed on the local client workstation, which could allow an unauthorized individual to potentially impact system availability and/or manipulate data.
Z-1569-2026 · View FDA record ↗ - GE Medical Systems, LLCOpen, ClassifiedMar 16, 2026
Centricity Universal Viewer Software Versions 6.0 through 6.0 Sp10.4.1, a device that displays medical images (including mammograms) and data from various imagi
There is a potential cybersecurity vulnerability affecting certain versions of Centricity Universal Viewer. User login credentials may be exposed on the local client workstation, which could allow an unauthorized individual to potentially impact system availability and/or manipulate data.
Z-1570-2026 · View FDA record ↗ - GE Medical Systems, LLCOpen, ClassifiedMar 16, 2026
Centricity Universal Viewer Software Versions 5.0 SP6 through UV 5.0 SP7.1, a device that displays medical images (including mammograms) and data from various i
There is a potential cybersecurity vulnerability affecting certain versions of Centricity Universal Viewer. User login credentials may be exposed on the local client workstation, which could allow an unauthorized individual to potentially impact system availability and/or manipulate data.
Z-1571-2026 · View FDA record ↗
Registered firms
1,989 firms currently registered for this product code
Therenva
Rennes Bretagne, FR
Agfa Healthcare N.v.
MORTSEL Antwerpen, BE
Ge Hangwei Medical Systems Co., Ltd.
Beijing, CN
Siemens Healthineers Ag
FORCHHEIM Bavaria, DE
Eigen
Grass Valley, CA, US
Ewoosoft Co., Ltd
Hwaseong-si Gyeonggi, KR
Materialise Usa, Llc.
Plymouth, MI, US
Spectrum Dynamics Medical Inc.
Sarasota, FL, US
Heartflow, Inc.
San Francisco, CA, US
Kls-martin L.p.
Jacksonville, FL, US
Cmr Naviscan Corporation
Carlsbad, CA, US
Materialise Sdn Bhd
Petaling Jaya Selangor, MY
Konica Minolta Technoproducts Co., Ltd.
SAYAMA-SHI Saitama, JP
Bio Analitica Argentina S.a.
Ciudad Autonoma de Buenos Aires, AR
Acumed Llc
Hillsboro, OR, US
Bioseal
PLACENTIA, CA, US
Unik Orthopedics, Inc
San Jose, CA, US
Intuitive Surgical, Inc.
Santa Clara, CA, US
Cd Newco, Llc.
Provo, UT, US
Medical Standard Co., Ltd.
Songpa-gu Seoul, KR
Ge Medical Systems Israel, Functional Imaging
Haifa, IL
Change Healthcare Canada Company
RICHMOND British Columbia, CA
510(k) clearances
2,283 clearances for this product code
- Neurocareai, Inc. (Dba Savelife.Ai)Jul 31, 2026
K260936 · RadioViewAI
- Cleerly, Inc.Jul 29, 2026
K260588 · Cleerly LABS
- Boston Scientific CorporationJul 24, 2026
K262462 · TheraSphere 360 Y-90 Management Platform
- Candelis, Inc.Jul 23, 2026
K262143 · ImageGrid StreamVue
- ResolutionMD, Inc.Jul 21, 2026
K260500 · ResolutionMD
- Avara SoftwareJul 10, 2026
K262120 · Avara Viewer
- Provect.AIJul 9, 2026
K253899 · 3D-Anywhere
- INDIGO TECHNOLOGIESJul 6, 2026
K261465 · INDIRA CLOUD VIEWER