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.
Recall
- Recall Number
- Z-1192-2012
- Event Number
- 61279
- Firm
- Visionsense, Ltd. 20 Hamagshimim St. Petach, Tikva Israel
- FEI Number
- 3003143838
- Product Code
- GWG
- Status
- Terminated
- Root Cause
- Nonconforming Material/Component
- Initiated
- March 21, 2011
- Posted
- March 8, 2012
- Terminated
- March 8, 2012
Description
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.
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
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 to the consignees.
Worldwide Distribution - USA including Arizona, Georgia, Pennsylvania, California, and the country of Turkey
Domestic - 17 units; Foreign - 4 units