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HYGEA
Hygea Medical Technology Co., Ltd. · Model Elite RBS20 · UDI-DI 06935650603124
GEH
Prescription
1
510(k) clearances
3,252
Adverse events (57 deaths)
107
Recalls
109
Facilities
Description
The Sterile Co-Ablation Probe, used in conjunction with the Co-Ablation System, is designed to destroy solid tumors, intended for use in open, minimally invasive or endoscopic surgical procedures in the areas in general surgery, urology, gynecology, oncology, neurology, dermatology, ENT, proctology, pulmonary surgery and thoracic surgery. The system is designed to Co-Ablate tissue by the application of extreme cold temperatures including prostate and kidney tissue, liver metastases, tumors, skin lesions, and warts.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-08-24 | Limitless Cryo Spa LLC | Lack of 510(k) clearance. |
| 2026-06-26 | Erbe USA Inc | A strong pull on the high-pressure transfer hose of cryosurgical unit may lead to pneumatic short circuit between he gas inlet and the connector resulting in CO2 leaking into the |
| 2026-02-12 | Erbe USA Inc | Probes may rupture/burst during activation |
| 2026-02-12 | Erbe USA Inc | Probes may rupture/burst during activation |
| 2026-02-12 | Erbe USA Inc | Probes may rupture/burst during activation |
| 2025-08-18 | Boston Scientific Corporation | Certain desiccant tube subassemblies were built with end caps that were not correctly tightened. |
| 2025-08-18 | Boston Scientific Corporation | Certain desiccant tube subassemblies were built with end caps that were not correctly tightened. |
| 2025-03-24 | Boston Scientific Corporation | Boston Scientific has identified that IceSeedTM CX needles manufactured between April 2024 and February 2025 have been programmed with DEMO settings instead of Commercial settings |
| 2025-03-24 | Boston Scientific Corporation | Boston Scientific has identified that IceSeedTM CX needles manufactured between April 2024 and February 2025 have been programmed with DEMO settings instead of Commercial settings |
| 2025-03-24 | Boston Scientific Corporation | Boston Scientific has identified that IceSeedTM CX needles manufactured between April 2024 and February 2025 have been programmed with DEMO settings instead of Commercial settings |
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Get your free API keyRead the docsData 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.