Recall Z-2261-2012 ยท GEH Unit, Cryosurgical, Accessories
Galil Medical, Inc.
Visual-ICE Cryoablation System, Model FPRCH 6000 Product Usage: The Galil Medical Visual-ICE Cryoablation System is intended for cryoablative destruction of tissue during minimally invasive procedures; various Galil Medical accessory products are required to perform these procedures. The Visual-ICE System is indicated for use as a cryosurgical tool in the fields of general surgery, dermatology, n
| Date | Aug 23, 2012 (initiated Jul 20, 2012) |
| Status | Terminated |
| Reason | Galil Medical is recalling a number of Visual Ice Cryoablation Systems because the gas regulators may fail to regulate the gas pressure, rendering the devices inoperable. |
| Root cause | Device Design |
| Action | Galil Medical sent a "Voluntary Medical Device Field Correction" letter dated July 20, 2012, via UPS to all affected customers. The letter identified the affected product, problem and actions to be taken. The letter states that a Galil Field Service team will be contacting customers to schedule a service visit the week of July 23rd. Customers were instructed to forward and communicate this field correction notice and instructions to individuals in their organization and/or to other organizations affected by this action. For questions call Galil Medical Customer Service. |
| Quantity | 4 |
| Distribution | Worldwide Distribution - US nationwide including the state of MN and the countries of United Kingdom and Netherlands |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K113860 | VISUAL-ICE CRYOABLATION SYSTEM Galil Medical, Inc., Mar 12, 2012 |