Visionsense Stereoscopic Vision System, Brand name VSII, Model/Part Numbers 172-0030 and 172-0040 --- Classification Nam

FDA device recall Z-1192-2012 · posted 2012-03-08 · Terminated

Recall details

Recalling firm

Visionsense, Ltd.

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

Action taken

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

Status

Terminated

Product code

GWG

Quantity affected

Domestic - 17 units; Foreign - 4 units

Distribution

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

Date initiated

2011-03-21

Date posted

2012-03-08

Date terminated

2012-03-08

Location

Tikva, Israel

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