FDA Enforcement
Class II
Ongoing
VS3 Iridium - Visionsense Infrared (IR) Fluorescence Miniature Microscope (MMS) - 785nm Product Number: 175-0012
Recall: Z-0281-2023
·
Reported November 30, 2022
Enforcement
- Recall Number
- Z-0281-2023
- Event ID
- 91055
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Visionsense, Ltd.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- N/A
- Report Date
- November 30, 2022
- Initiation Date
- October 17, 2022
- Classification Date
- November 23, 2022
- Address
- 20, Ha-Magshimim, N/A, Petakh Tikva, N/A, N/A, Israel
Description
VS3 Iridium - Visionsense Infrared (IR) Fluorescence Miniature Microscope (MMS) - 785nm Product Number: 175-0012
Reason
XXX
Code Info
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
Distribution
US Nationwide distribution.
Quantity
34 units: 15 units OUS; 19 units US