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Betters (Suzhou)Medical Co., Ltd.
Betters (Suzhou)Medical Co., Ltd. · Model T-1408 · UDI-DI 06975283422013
NEY
Prescription
1
510(k) clearances
1,784
Adverse events (45 deaths)
27
Recalls
40
Facilities
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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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.