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Fan Beam Collimator Asm Symbia

SIEMENS MEDICAL SOLUTIONS USA, INC. · Model 07332062 · UDI-DI 04056869002019

KPS
1
510(k) clearances
1,052
Adverse events (8 deaths)
449
Recalls
82
Facilities

Recalls

DateFirmReason
2026-08-11Shanghai 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
2026-08-11Shanghai 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
2026-08-11Shanghai 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
2026-08-11Shanghai 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
2026-08-11Shanghai 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
2026-08-11Shanghai 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
2025-12-24GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGINGThere 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
2025-12-10GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGINGGE 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
2025-12-10GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGINGGE 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
2025-09-12GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGINGGE 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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Data 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.