FDA recall Z-0282-2023

Product

VS3 Iridium Visionsense Infrared (IR) Fluorescence Light Integrator (Beam Combiner) Product Number: 161-0001

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.

Key facts

Status

Ongoing

Initiation date

2022-10-17

Report date

2022-11-30

Voluntary/Mandated

Voluntary: Firm initiated

Location

Petakh Tikva, N/A, Israel

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0282-2023