Class 2 Device Recall VisionSense

• Date Initiated by Firm: October 17, 2022
• Date Posted: November 23, 2022
• Recall Status: Open, Classified
• Recall Number: Z-0281-2023
• Recall Event ID: 91055
• 510(K)Number: K150018
• Product Classification: Confocal optical imaging - Product Code OWN
• Product: VS3 Iridium - Visionsense Infrared (IR) Fluorescence Miniature Microscope (MMS) - 785nm Product Number: 175-0012
• Code Information: UDI-DI: 10813040013711 Lot Numbers: Serial Number/Lot Number 378-4005 378-4514 378-4516 378-4517 378-4518 378-4519 378-4520 378-4521 378-4522 378-4523 378-4525 378-4526 378-4527 378-4528 378-4534 378-4586 3784692 3784693 3784694 3784696 3784700 3784701 3784702 3784703 3784704 3784784 3784786 3784787 3784802 3784803 3784807 3784808 3784874 3784875
• Recalling Firm/ Manufacturer: Visionsense, Ltd.; 20, Ha-Magshimim; Petakh Tikva Israel
• For Additional Information Contact: Medtronic Customer Service ; 800-962-9888
• Manufacturer Reason for Recall: XXX
• FDA Determined Cause: Under Investigation by firm
• Action: Medtronic issued Urgent Medical Device Correction Letter on 17-OCTOBER-2022 to US consignees via UPS 2-day delivery. For outside U.S. countries, notifications are handled via a regionally approved method. Letter states reason for recall, health risk and action to take: 1.Prior to use, visually check the Beam-Combiner and MMS optical fiber cable for signs of being pinched, kinkedor damaged. Avoid folding the cables and handle with care to prevent damage. 2.After the white balance has been performed as per IFU guidance, test the EleVision IR system at the beginningof the surgical procedure as follows: a)Turn on the laser. b)For the laparoscopic configuration of the EleVision IR system, point the distal end of the endoscopetowards a bright surface, keeping the scope approximately 3 cm from the target. This prevents thewhite light from scattering. For the open configuration of the EleVision IR system, position the distalface of the MMS approximately 30 cm from any object. If you see a message on the screen indicatingthat the device is too close to tissue, move the device further away from the object until this messagedisappears. c)After two (2) seconds, the monitor screen should show a message indicating that the laser is on, ablinking red dot, and a running clock. If all these indications are seen properly on the monitor screen,turn off the laser after five (5) seconds. If the screen does not show an indication that the laser is on, a blinking red dot, and a running clock, the laser is not functioning properly and the EleVision IR system should not be used in the surgical procedure. If any pinching, kinking, or damage of the optical fiber cable is noted, or if the system does not work properly during the above-described laser test, do not use the system. Please report a complaint and arrange for servicing of the Beam Combiner and / or MMS device by contacting Medtronic at 1-800-255-6774 or rs.serviceexperience@medtronic.com. Additional actions: "Immediately notify
• Quantity in Commerce: 34 units: 15 units OUS; 19 units US
• Distribution: US Nationwide distribution.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = OWN