Visionsense Infrared Microscope Recalled Due to Optical Fiber Cable Damage
Visionsense is recalling 205 units of its VS3 Iridium microscope because optical fiber cables may become damaged during handling, causing loss of function and outer cable heating or melting.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of a medical device with risk-of-harm potential (cable heating/melting), but no illnesses or injuries have been reported. Per the rubric, risk-of-harm products without reported injury warrant a High (3) severity rating.
Plain-English summary
Visionsense, Ltd. is recalling 205 units of the VS3 Iridium Visionsense Infrared (IR) Fluorescence Miniature Microscope, Product Number 174-0012. The United States distribution includes 111 units, while 94 units were distributed outside the United States.
The optical fiber cable in the microscope can suffer damage through normal handling or bending. This damage can lead to loss of microscope functionality and heating or melting of the outer cable surface.
Customers with this product should contact Visionsense, Ltd. for instructions on how to handle the recall. The recall encompasses multiple lot numbers of the affected product.
The recalled product
- Product
- VS3 Iridium Visionsense Infrared (IR) Fluorescence Miniature Microscope (MMS-IR) Product Number: 174-0012
- 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 →- ModerateMedical device recall: VS3 Iridium infrared fluorescence microscope
FDA (Devices) · 2022-11-30
- HighVS3 Iridium Visionsense Beam Combiner Optical Fiber Cable Damage Risk
FDA (Devices) · 2022-11-30
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