Device recall: VS3 Iridium Visionsense Infrared (IR) Fluorescence Miniature Microscope (MMS-IR) Product Number: 174-0012
FDA enforcement event 91055 is a device recall by Visionsense, Ltd. of Petakh Tikva, N/A, initiated 17 Oct 2022 and classified Class II, with 3 product records.
FDA defines Class II as 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. 88% of the 839 device enforcement events initiated in 2022 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. This is the only enforcement event on this register for Visionsense, Ltd..
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Visionsense, Ltd., Petakh Tikva, N/A, Israel.
Reason for recall
"Broken Optical fiber cable damage can occur through handling or bending and can lead to loss of functionality and heating/melting of the outer cable surface."
Distribution
"US Nationwide distribution."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0280-2023 | VS3 Iridium Visionsense Infrared (IR) Fluorescence Miniature Microscope (MMS-IR) Product Number: 174-0012 | 205 units: 94 units OUS; 111 units US | Class II | Ongoing | 30 Nov 2022 |
| Z-0281-2023 | VS3 Iridium - Visionsense Infrared (IR) Fluorescence Miniature Microscope (MMS) - 785nm Product Number: 175-0012 | 34 units: 15 units OUS; 19 units US | Class II | Ongoing | 30 Nov 2022 |
| Z-0282-2023 | VS3 Iridium Visionsense Infrared (IR) Fluorescence Light Integrator (Beam Combiner) Product Number: 161-0001 | 204 units: 93 units OUS ; 111 units US | Class II | Ongoing | 30 Nov 2022 |
Context
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Broken Optical fiber cable damage can occur through handling or bending and can lead to loss of functionality and heating/melting of the outer cable surface."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. 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.
Where was the product distributed?
FDA's distribution pattern field reads: "US Nationwide distribution."
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.