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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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.
Part of a larger recall action
This product is one of 3 recalled by Visionsense, Ltd. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
Same manufacturer · Visionsense, Ltd.
See all →- HighVisionsense Infrared Microscope Recalled Due to Optical Fiber Cable Damage
FDA (Devices) · 2022-11-30
- HighVS3 Iridium Visionsense Beam Combiner Optical Fiber Cable Damage Risk
FDA (Devices) · 2022-11-30
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