VS3 Iridium Visionsense Beam Combiner Optical Fiber Cable Damage Risk
Visionsense VS3 Iridium beam combiners may develop damaged optical fiber cables through handling or bending, causing loss of functionality and potential cable heating or melting. Affected units were distributed nationwide in the US.
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 for optical fiber cable damage that may cause heating and melting, presenting a burn risk. No injuries have been reported, meeting the rubric criterion of 'risk-of-harm products where injury has not yet been reported,' resulting in a High severity score.
Plain-English summary
The Visionsense VS3 Iridium Visionsense Infrared Fluorescence Light Integrator (Beam Combiner), Product Number 161-0001, is being recalled due to potential damage to the product's optical fiber cable.
The optical fiber cable can become damaged through normal handling or bending during use, which may result in loss of functionality and heating or melting of the outer cable surface.
A total of 111 units were distributed within the United States on a nationwide basis, and 93 units were distributed outside the United States. The affected product includes multiple lot numbers and serial numbers as documented in the FDA recall notice.
The recalled product
- Product
- VS3 Iridium Visionsense Infrared (IR) Fluorescence Light Integrator (Beam Combiner) Product Number: 161-0001
- 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
- HighVisionsense Infrared Microscope Recalled Due to Optical Fiber Cable Damage
FDA (Devices) · 2022-11-30
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