Home › Galvanize Therapeutics, Inc. › Aliya Generator-Recertified
Aliya Generator-Recertified
Galvanize Therapeutics, Inc. · Model GTI-00017R · UDI-DI 00850031859104
OAB
Prescription
1
510(k) clearances
233
Adverse events (9 deaths)
4
Recalls
17
Facilities
Description
Aliya Generator - recertified
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-03-02 | Angiodynamics, Inc. | Not programmed in accordance with specification. The programming affects the RFID function and does not allow the NanoKnife probes to be recognized by the NanoKnife generator resul |
| 2020-04-24 | Angiodynamics, Inc. | Programming issue affected RFID function of a single lot and did not allow the NanoKnife probes to be recognized by the NanoKnife generator. |
| 2012-01-20 | Angiodynamics Worldwide Headquarters | Angiodynamics was marketing the NanoKnife System with the ablation zone estimator feature in the US without FDA clearance. |
| 2011-04-04 | Angiodynamics, Inc. | Some units of Nanoknife have the potential to deliver a shortened pulse width without indicating an error. The affected units contain a "GOMe" circuit board which may cause the ge |
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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.