Recall Z-1192-2012 ยท GWG Endoscope, Neurological
Visionsense, Ltd.
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 f
| Date | Mar 8, 2012 (initiated Mar 21, 2011) |
| Status | Terminated |
| Reason | A complaint was received and a unit returned that exhibited the metal and glass shaft window becoming dislodged during scope cleaning. Additionally, during in-process visual inspection of the metal and glass shaft window sub-assembly from a specific batch that was received from the supplier it was noted that the window at the tip of the scope was not seated properly. It was determined that the wi |
| Root cause | Nonconforming Material/Component |
| Action | Visionsense Ltd. sent URGENT DEVICE RECALL and URGENT DEVICE RECALL/FIELD SAFETY NOTICE letter dated March 21, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer and included a return "fax" form in the recall communication package. The letters were sent via UPS express service. All direct consignees were contacted, and follow up phone calls conducted if needed. The recall required the return of all affected units for inspection and/or repair. Visionsense provided a return authorization number and packing instructions |
| Quantity | Domestic - 17 units; Foreign - 4 units |
| Distribution | Worldwide Distribution - USA including Arizona, Georgia, Pennsylvania, California, and the country of Turkey |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K081102 | VSU - VISIONSENSE STEREOSCOPIC VISION SYSTEM Visionsense, Ltd., May 29, 2008 |