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CROMA Electrosurgical Generator

CREO MEDICAL LIMITED · Model 7-EMR-050 V6.001 · UDI-DI 05060359561183

KNS Prescription

510(k) clearances

17,612

Adverse events (83 deaths)

125

Recalls

118

Facilities

Description

The Electrosurgical Generator is intended to provide Radiofrequency (RF) and microwave (MW) energy for cutting, coagulation, and ablation of soft tissue, when used in conjunction with compatible electrosurgical instruments and accessories.

Recalls

Date	Firm	Reason
2026-08-19	Olympus Corporation of the Americas	Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive.
2026-08-19	Olympus Corporation of the Americas	Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive.
2026-08-19	Olympus Corporation of the Americas	Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive.
2026-08-19	Olympus Corporation of the Americas	Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive.
2026-01-07	Olympus Corporation of the Americas	Devices which did not undergo thermoforming could deform and lose performance.
2026-01-07	Olympus Corporation of the Americas	Devices which did not undergo thermoforming could deform and lose performance.
2026-01-07	Olympus Corporation of the Americas	Devices which did not undergo thermoforming could deform and lose performance.
2026-01-07	Olympus Corporation of the Americas	Devices which did not undergo thermoforming could deform and lose performance.
2026-01-07	Olympus Corporation of the Americas	Devices which did not undergo thermoforming could deform and lose performance.
2026-01-07	Olympus Corporation of the Americas	Devices which did not undergo thermoforming could deform and lose performance.

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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.