VS3 Iridium - Visionsense Infrared (IR) Fluorescence Miniature Microscope (MMS) - 785nm Product Number: 175-0012
Summary
The FDA issued a Class II for VS3 Iridium - Visionsense Infrared (IR) Fluorescence Miniature Microscope (MMS) by Visionsense, Ltd.. Reason: XXX.
Details
Source
Device Recall
External ID
Z-0281-2023
Action Date
2022-11-30
Status
Ongoing
Category
device
Product Description
VS3 Iridium - Visionsense Infrared (IR) Fluorescence Miniature Microscope (MMS) - 785nm Product Number: 175-0012
Lot/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
Quantity Affected: 34 units: 15 units OUS; 19 units US
Reason for Recall
XXX
Distribution
US Nationwide distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-10-17
Company
Petakh Tikva, N/A
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 152 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Visionsense, Ltd. has 5 FDA actions in our database, including 3 recalls and 2 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Visionsense, Ltd.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Visionsense, Ltd. have FDA actions?
Visionsense, Ltd. has 5 FDA actions in our database, including 3 recalls and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0281-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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