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

FDA Device Recall #Z-0280-2023 — Class II — October 17, 2022

Recall Summary

Recall Number Z-0280-2023
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 205 units: 94 units OUS; 111 units US

Product Description

VS3 Iridium Visionsense Infrared (IR) Fluorescence Miniature Microscope (MMS-IR) Product Number: 174-0012

Reason for Recall

Broken Optical fiber cable damage can occur through handling or bending and can lead to loss of functionality and heating/melting of the outer cable surface.

Distribution Pattern

US Nationwide distribution.

Lot / Code Information

UDI-DI: 18130400103489 Lot Numbes: 3784719 3784735 3784751 378-4001 378-4002 378-4003 378-4004 378-4006 378-4007 378-4008 378-4009 378-4010 378-4012 378-4013 378-4014 378-4015 378-4016 378-4017 378-4020 378-4021 378-4501 378-4502 378-4503 378-4504 378-4505 378-4506 378-4507 378-4508 378-4510 378-4511 378-4512 378-4513 378-4515 378-4529 378-4531 378-4535 378-4537 3784581 378-4582 378-4583 378-4584 378-4588 378-4589 378-4590 3784592 378-4593 378-4594 3784595 378-4596 3784599 3784601 378-4602 3784603 378-4604 3784605 3784606 3784609 3784610 3784612 3784613 3784614 3784617 378-4618 3784619 3784620 3784621 3784622 3784623 3784624 3784626 3784627 3784628 3784629 3784632 3784633 3784635 3784636 3784637 3784638 3784641 3784644 3784645 3784646 3784648 3784649 3784650 3784651 3784652 3784653 3784654 3784656 378-4657 378-4658 3784659 3784660 3784661 3784662 3784663 3784664 3784665 3784666 3784667 3784669 3784671 3784672 3784674 378-4675 3784676 378-4677 3784679 3784680 3784681 3784682 3784683 3784685 3784686 3784687 3784688 3784689 3784691 3784705 3784706 3784708 3784713 3784715 3784716 3784717 3784718 3784720 3784721 3784723 3784725 3784726 3784727 3784728 378-4729 3784731 3784732 3784733 3784734 3784736 3784738 378-4739 378-4740 378-4742 3784743 3784744 378-4745 3784746 3784752 3784753 3784755 3784757 3784758 3784759 3784760 3784761 3784762 3784763 3784764 3784765 3784766 378-4767 378-4768 378-4769 3784775 3784776 3784777 3784779 3784780 3784781 3784789 3784790 3784791 3784792 3784793 3784798 3784799 3784801 378-4805 378-4806 3784809 3784811 3784812 3784813 3784819 3784821 3784822 3784824 3784825 3784826 3784827 3784828 378-4829 3784834 3784837 3784838 3784839 3784841 378-4858 3784863 3784864 3784865 3784867 3784868

Other Recalls from Visionsense, Ltd.

Recall # Classification Product Date
Z-0281-2023 Class II VS3 Iridium - Visionsense Infrared (IR) Fluores... Oct 17, 2022
Z-0282-2023 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.

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