Visual-ICE Cryoablation System, Model FPRCH 6000 Product Usage: The Galil Medical Visual-ICE Cryoablation System is inte
FDA device recall Z-2261-2012 · posted 2012-08-23 · Terminated
Recall details
- Recalling firm
- Galil Medical, Inc.
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- GEH
- Quantity affected
- 4
- Distribution
- Worldwide Distribution - US nationwide including the state of MN and the countries of United Kingdom and Netherlands
- Date initiated
- 2012-07-20
- Date posted
- 2012-08-23
- Date terminated
- 2012-09-13
- Location
- Arden Hills, MN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VISUAL-ICE CRYOABLATION SYSTEM (K113860) | Galil Medical, Inc. | 2012-03-12 |