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Recall Observatory FDA recall evidence

Device product

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

Z-0281-2023

October 17, 2022

Class II

Product summary

Firm
Visionsense, Ltd.
Event
Event 91055
Status
Ongoing
Classification
Class II
Quantity
34 units: 15 units OUS; 19 units US
Official record key
device-enforcement:Z-0281-2023

Official wording

Reason: XXX

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

Distribution pattern: US Nationwide distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    XXX