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 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 number

Z-1192-2012

Recalling firm

Visionsense, Ltd.

Product

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.

Status

Terminated

Initiated

2011-03-21

Posted

2012-03-08

Terminated

2012-03-08

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 to the consignees.

Quantity

Domestic - 17 units; Foreign - 4 units

Distribution

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

Lot, serial or model codes

Model/Part Number 172-0030 serial numbers: 370-1330, 370-1379, 370-1469, 370-1316, 370-1452, 370-1482, 370-1335, 370-1450, 370-1479, 370-1406, 370-1443; Model/Part Number 172-0040 serial numbers: 370-1457 DEMO, 370-1477 DEMO, 370-1345 DEMO, 370-1438 DEMO, 370-1396 DEMO, 370-1437 DEMO, 370-1428 DEMO, 370-1470 DEMO, 370-1398 DEMO, 370-1440 DEMO

510(k) numbers

["K081102"]

PMA numbers

not on file

Product code

GWG

Firm FEI

3003143838

Firm city

Tikva

Firm state

not on file

Firm country

Israel

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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