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Hybrid3D
Hermes Medical Solutions AB · Model 00859873006073 · UDI-DI 00859873006073
KPS
Prescription
10
510(k) clearances
1,054
Adverse events (8 deaths)
449
Recalls
84
Facilities
Description
Hybrid3D is a software application that can be used to process, display, analyze and manage nuclear medicine and other medical imaging data transferred from other workstations or acquisition stations. The Lung Lobe Quantification module in Hybrid3D introduces an efficient and automated workflow solution to compute 3D lobar anatomy from CT (with or without contrast). Functional images (SPECT V/Q, SUV SPECT, CT iodine maps, hyperpolarized xenon MRI, etc.) can also be include in the analysis to relate lobar anatomy to function.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-08-11 | Shanghai United Imaging Healthcare Co., Ltd. | Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are merged into a single |
| 2026-08-11 | Shanghai United Imaging Healthcare Co., Ltd. | Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are merged into a single |
| 2026-08-11 | Shanghai United Imaging Healthcare Co., Ltd. | Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are merged into a single |
| 2026-08-11 | Shanghai United Imaging Healthcare Co., Ltd. | Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are merged into a single |
| 2026-08-11 | Shanghai United Imaging Healthcare Co., Ltd. | Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are merged into a single |
| 2026-08-11 | Shanghai United Imaging Healthcare Co., Ltd. | Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are merged into a single |
| 2025-12-24 | GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING | There is a potential intermittent issue on certain Omni Legend systems that can result in a streaking artifact in the PET clinical scan images. This streaking artifact is most eas |
| 2025-12-10 | GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING | GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service (herein referred to as Impacted Systems and listed in the Affecte |
| 2025-12-10 | GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING | GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service (herein referred to as Impacted Systems and listed in the Affecte |
| 2025-09-12 | GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING | GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service could have been transported or relocated without adequate detector |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.