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MAMMI

GENERAL EQUIPMENT FOR MEDICAL IMAGING SA · Model MAMMI DR · UDI-DI 08437018413041

KPS Prescription

510(k) clearances

1,051

Adverse events (8 deaths)

443

Recalls

Facilities

Description

MAMMI is a Positron Emission Tomography (PET) system for medical imaging applications and for measuring the distribution of positron-emitting radiodrugs administered to patients to detect breast cancer. The system MAMMI presents two modalities: - Breast PET Mammography System with a single ring detector and a prone examination bed. - Breast PET Mammography System with a double ring detector and a prone examination bed (this record).

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.