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HYGEA

Hygea Medical Technology Co., Ltd. · Model Ease TML15A · UDI-DI 06935650626451

NEY Prescription

510(k) clearances

1,798

Adverse events (45 deaths)

Recalls

Facilities

Description

The Sterile Temperature Probe is intended to be used in conjunction with the Exceed S10U microwave ablation device manufactured by Hygea Medical Technology Co., Ltd. to measure the temperature of solid tumors and surrounding tissues.

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.