VS3 Iridium - Visionsense Infrared (IR) Fluorescence Miniature Microscope (MMS) - 785nm Product ...

FDA Device Recall #Z-0281-2023 — Class II — October 17, 2022

Recall Summary

Recall Number Z-0281-2023
Classification Class II — Moderate risk
Date Initiated October 17, 2022
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Visionsense, Ltd.
Location Petakh Tikva, N/A
Product Type Devices
Quantity 34 units: 15 units OUS; 19 units US

Product Description

VS3 Iridium - Visionsense Infrared (IR) Fluorescence Miniature Microscope (MMS) - 785nm Product Number: 175-0012

Reason for Recall

XXX

Distribution Pattern

US Nationwide distribution.

Lot / 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

Other Recalls from Visionsense, Ltd.

Recall # Classification Product Date
Z-0282-2023 Class II VS3 Iridium Visionsense Infrared (IR) Fluoresce... Oct 17, 2022
Z-0280-2023 Class II VS3 Iridium Visionsense Infrared (IR) Fluoresce... Oct 17, 2022

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.