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Affinity

Hermes Medical Solutions AB · Model 2.0 · UDI-DI 00859873006141

KPS Prescription

510(k) clearances

1,051

Adverse events (8 deaths)

443

Recalls

Facilities

Description

AFFINITY is a software application used to process, display, analyse and manage nuclear medicine and other medical imaging data transferred from other workstations, PACS or acquisition stations. The information acquired from viewing the images is used, in conjunction with other patient related data, for diagnosis and monitoring of disease.

Recalls

Date	Firm	Reason
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
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
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
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
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
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
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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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.