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LOGIQ

GE Ultrasound Korea Ltd. · Model Fortis R3R4_R5 UPG · UDI-DI 00198953109434

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510(k) clearances

Adverse events

Recalls

242

Facilities

Description

LOGIQ Fortis R3R4 to R5 SW Upgrade

Recalls

Date	Firm	Reason
2026-05-07	PIE Medical Imaging B.V.	User measurement value reported by diagnostic bioimaging software intended to measure/visualize cardiovascular structures may be larger (0.8% to 34.4%) than the actual anatomical d
2021-05-19	Caption Health	The firm is aware of a issue with ultrasound software that results in unintended video frames being included. This could lead to an incorrect automated ejection fraction (AutoE

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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.