Device Recall VSII

  • Modèle / numéro de série
    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
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA including Arizona, Georgia, Pennsylvania, California, and the country of Turkey
  • Description du dispositif
    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

Fabricant

  • Adresse du fabricant
    Visionsense, Ltd., 20 Hamagshimim St., Petach, Tikva Israel
  • Société-mère du fabricant (2017)
  • Source
    USFDA