Home › Varian Medical Systems, Inc. › IntelliBlate Ximitry Probe Assembly, 13G x 20cm
IntelliBlate Ximitry Probe Assembly, 13G x 20cm
Varian Medical Systems, Inc. · Model IB-XPA-1320 · UDI-DI 00810563022308
1
510(k) clearances
1,798
Adverse events (45 deaths)
27
Recalls
40
Facilities
Description
IntelliBlate Ximitry probe assembly includes cassette with saline tubing, Ximitry laser alignment disc, and microwave ablation probe 13G/20cm Probe QTY 1
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 |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
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.