4 results
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29ms
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Sources: EU EUDAMED, US FDA
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FDA Recall
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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.
FDA Recall
Terminated
·Visionsense, Ltd. 20 Hamagshimim St. Petach, Tikva Israel·Product code GWG·March 21, 2011
VS3 Iridium Visionsense Infrared (IR) Fluorescence Miniature Microscope (MMS-IR) Product Number: 174-0012
FDA Recall
Open, Classified
·Visionsense, Ltd. 20, Ha-Magshimim Petakh Tikva Israel·Product code OWN·October 17, 2022
VS3 Iridium Visionsense Infrared (IR) Fluorescence Light Integrator (Beam Combiner) Product Number: 161-0001
FDA Recall
Open, Classified
·Visionsense, Ltd. 20, Ha-Magshimim Petakh Tikva Israel·Product code OWN·October 17, 2022
VS3 Iridium - Visionsense Infrared (IR) Fluorescence Miniature Microscope (MMS) - 785nm Product Number: 175-0012
FDA Recall
Open, Classified
·Visionsense, Ltd. 20, Ha-Magshimim Petakh Tikva Israel·Product code OWN·October 17, 2022