Device Recall VSII

  • Modelo / Serial
    Model/Part Number 172-0030 serial numbers: 370-1330, 370-1379, 370-1469, 370-1316, 370-1452, 370-1482, 370-1335, 370-1450, 370-1479, 370-1406, 370-1443; Model/Part Number 172-0040 serial numbers: 370-1457 DEMO, 370-1477 DEMO, 370-1345 DEMO, 370-1438 DEMO, 370-1396 DEMO, 370-1437 DEMO, 370-1428 DEMO, 370-1470 DEMO, 370-1398 DEMO, 370-1440 DEMO
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA including Arizona, Georgia, Pennsylvania, California, and the country of Turkey
  • Descripción del producto
    Visionsense Stereoscopic Vision System, Brand name VSII, Model/Part Numbers 172-0030 and 172-0040 --- Classification Name: Neurological Endoscope --- NOTE: Model Numbers 172-0032, 172-0044, 172-0070, 172-0072, 172-0080 were also included in the firm's recall action but these never entered US commerce. These were distributed directly from Israel to the foreign consignees. --- The VSII is intended for viewing internal surgical sites during general surgical procedures and for use in visualization of ventricles and structures within the brain during neurological surgical procedures. These devices do not carry an expiration date. However, they are automatically taken out of service and replaced after 40 uses.
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Visionsense, Ltd., 20 Hamagshimim St., Petach, Tikva Israel
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA