Medical device recall: VS3 Iridium infrared fluorescence microscope
Visionsense, Ltd. issued a voluntary Class II recall of the VS3 Iridium infrared fluorescence microscope affecting 34 units with US Nationwide distribution.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is a voluntary, firm-initiated Class II medical device recall with no reported injuries or illnesses mentioned in the source. Per the severity rubric, voluntary precautionary recalls are classified as Moderate (2).
Plain-English summary
Visionsense, Ltd. has voluntarily recalled the VS3 Iridium infrared fluorescence miniature microscope (Product Number 175-0012, 785nm). The FDA classified this as a Class II recall.
The recall affects 34 total units: 19 distributed within the United States and 15 units distributed outside the United States. The product received US Nationwide distribution. The Universal Device Identifier (UDI-DI) is 10813040013711. Affected lot numbers include Serial Numbers 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, and 3784875.
The company initiated this recall on October 17, 2022. The FDA confirmed the recall classification on November 23, 2022. If you own or operate one of the affected devices, contact Visionsense, Ltd. for further instructions.
The recalled product
- Product
- VS3 Iridium - Visionsense Infrared (IR) Fluorescence Miniature Microscope (MMS) - 785nm Product Number: 175-0012
- Manufacturer
- Visionsense, Ltd.
Distribution
Distributed nationwide across the United States.
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