Drug recall
Visual-ICE Cryoablation System, FPRCH6000. The cryoablation system is a mobile console system intended for…
FDA recall event 84120 · Class II · Galil Medical, Inc.
Key facts
| Event ID | 84120 |
|---|---|
| Recall numbers | Z-0404-2020 |
| Recalling firm | Galil Medical, Inc. |
| Product type | Devices |
| Products | Visual-ICE Cryoablation System, FPRCH6000. The cryoablation system is a mobile console system intended for cryoablative tissue destruction using a minimally invasive procedure. The system is… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Visual-ICE utilizing the IceSeed 1.5 and IceRod 1.5 PLUS cryoablation needles could have issues with the needle clogging and/or inadequate freezing performance. |
| Initiation date | Oct 25, 2019 |
| Report date | Nov 20, 2019 |
| Termination date | Sep 16, 2020 |
| City | Saint Paul |
| State | MN |
| Country | United States |
| FEI number | 3004462490 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: