Z-1192-2012

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

Name: Z-1192-2012 Visionsense Stereoscopic Vision System, Brand name VSII, Model/Part Numbers 172-0030 and 172-0040...
Creator: Visionsense, Ltd.
Published: 2011-03-21
License: https://open.fda.gov/license/

Visionsense, Ltd. / initiated 2011-03-21 / Terminated / root cause: manufacturing process

FDA source

Visionsense, Ltd. began a recall of Visionsense Stereoscopic Vision System, Brand name VSII, Model/Part Numbers 172-0030 and 172-0040 --- Classification Name: Neurological Endoscope --- NOTE... on 2011-03-21. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1192-2012
Status: Terminated
Initiated: 2011-03-21
Posted: 2012-03-08
Terminated: 2012-03-08
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.
Product code: GWG Endoscope, Neurological
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
Root cause tag: manufacturing process
FDA 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 in commerce: Domestic - 17 units; Foreign - 4 units
Distribution: Worldwide Distribution - USA including Arizona, Georgia, Pennsylvania, California, and the country of Turkey
Product codes and lots: 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

Product code GWG

K081102Class IIVsu - Visionsense Stereoscopic Vision SystemVisionsense, Ltd. / cleared 2008-05-29

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)