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HYGEA

Hygea Medical Technology Co., Ltd. · Model Exact HP-1512200U · UDI-DI 06935650621371

NEY Prescription

510(k) clearances

1,798

Adverse events (45 deaths)

Recalls

Facilities

Description

Sterile Microwave Ablation Probe is used with Microwave Ablation Device, which is indicated for soft tissue coagulation(ablation) by healthcare professionals in healthcare facilities. Sterile Microwave Ablation Probe is not intended for cardiac use.

Recalls

Date	Firm	Reason
2022-11-23	Covidien, LLC	The product is labeled with the incorrect expiration date.
2021-09-29	Covidien Llc	The firm identified an error in the device temperature monitoring circuitry which is designed to interrupt energy delivery in the event of a primary cooling system failure. Use of
2021-07-20	Angiodynamics, Inc.	Specific serial numbers of the Solero MTA Generator require servicing to upgrade the software to help reduce the incidence of Error 0001, which can occur during system start-up.
2021-07-20	Angiodynamics, Inc.	Specific serial numbers of the Solero MTA Generator require servicing to upgrade the software to help reduce the incidence of Error 0001, which can occur during system start-up.
2021-07-20	Angiodynamics, Inc.	Specific serial numbers of the Solero MTA Generator require servicing to upgrade the software to help reduce the incidence of Error 0001, which can occur during system start-up.
2021-07-20	Angiodynamics, Inc.	Specific serial numbers of the Solero MTA Generator require servicing to upgrade the software to help reduce the incidence of Error 0001, which can occur during system start-up.
2019-04-17	Angiodynamics Inc. (Navilyst Medical Inc.)	Updated Warning Statements in the Operator's Manual/Directions for Use and Software Updates to reduce the risk of potential patient harm due to a delay in performing a procedure
2019-04-17	Angiodynamics Inc. (Navilyst Medical Inc.)	Updated Warning Statements in the Operator's Manual/Directions for Use and Software Updates to reduce the risk of potential patient harm due to a delay in performing a procedure
2019-04-17	Angiodynamics Inc. (Navilyst Medical Inc.)	Updated Warning Statements in the Operator's Manual/Directions for Use and Software Updates to reduce the risk of potential patient harm due to a delay in performing a procedure
2019-04-17	Angiodynamics Inc. (Navilyst Medical Inc.)	Updated Warning Statements in the Operator's Manual/Directions for Use and Software Updates to reduce the risk of potential patient harm due to a delay in performing a procedure

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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.