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Ra Medical Systems Inc recalls The DABRA Laser (model RA-308) is designed to provide ultraviolet laser energy endovascularly through a catheter to occl
Recalled August 14, 2019 · FDA recall Z-2218-2019 · Ra Medical Systems
Hazard
Lasers/Catheters did not calibrate during set-up prior to use. · FDA Class II
Units
4
Sold at
U.S: CA, PA
Description
Lasers/Catheters did not calibrate during set-up prior to use.
Product
The DABRA Laser (model RA-308) is designed to provide ultraviolet laser energy endovascularly through a catheter to occluded lesions in the peripheral arteries to cross them. The system is a self-contained unit that consists of a light source unit and a single use catheter. The light source contains a microprocessor with software to provide safety features and a user-friendly interface. The laser operates by producing a high current discharge within a chamber that is filled with rare gases and halogen. The discharge produces pulses of UV light, which is amplified by reflecting the energy within the resonating chamber many times. The output is directed to the desired target location by the catheter. A footswitch connected to the light source controls the laser action.
Manufacturer(s)
Ra Medical Systems Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →