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Cedars-Sinai Cardiac Suite

CEDARS-SINAI MEDICAL CENTER · Model 2017 · UDI-DI 00864687000247

KPS
1
510(k) clearances
1,054
Adverse events (8 deaths)
449
Recalls
84
Facilities

Description

The Cedars-Sinai Cardiac Suite is a stand-alone software solution for Cardiac SPECT and PET imaging processing and review. The Cedars-Sinai Cardiac Suite operates on camera independent reconstructed SPECT and/or PET image files. Cedars-Sinai Cardiac Suite will be marketed as a comprehensive application suite that includes QGS (Quantitative Gated SPECT), QPS (Quantitative Perfusion SPECT) and CSImport applications. This allows automatic processing and review of quantitative and qualitative information generated by nuclear medicine studies. Purchasable Options consist of Quantitative Blood Pool SPECT (QBS), QARG (for reporting purposes), Fusion (SPECT/CT/CTA and/or PET/CT/CTA), Motion Correction (MOCO) and QPET. QPET also includes viability quantification and two additional databases (rubidium and ammonia) for processing PET studies.

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.