FDAFDA · Alimentos y medicamentos·N.º oficial Z-2261-2012
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, neurology (including cryoanalgesia), thoracic surgery, ENT, gynecology, oncology, proctology, and urology. This system is designed to destroy tissue (including prostate and kidney tissue, liver metastases, tumors, skin lesions, and warts) by the application of extremely cold temperatures.
Publicado el 29 de agosto de 2012 · Inicio del retiro: 20 de julio de 2012
Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
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.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Galil Medical, Inc.
- Distribuidor
- Worldwide Distribution - US nationwide including the state of MN and the countries of United Kingdom and Netherlands
- Lote
- VL0004 VL0014 VL0015 VL0016
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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