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Terminated

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 Z-1192-2012 · Posted 2012-03-08

Recalling FirmVisionsense, Ltd.
Recall StatusTerminated
Product CodeGWG
Date Initiated2011-03-21
Date Terminated2012-03-08
Product QuantityDomestic - 17 units; Foreign - 4 units

Reason for Recall

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

Firm 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 to the consignees.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Worldwide Distribution - USA including Arizona, Georgia, Pennsylvania, California, and the country of Turkey

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K081102VSU - VISIONSENSE STEREOSCOPIC VISION SYSTEMVisionsense, Ltd. · 2008-05-29

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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