Ra Medical Systems Inc recalls The DABRA Laser (model RA-308) is designed to provide ultraviolet laser energy endovascularly through a catheter to occ…

Recall date

February 15, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2218-2019

FDA classification

Class II

Brand / firm

Ra Medical Systems Inc

Sold / distributed

U.S: CA, PA

Why it was recalled

Lasers/Catheters did not calibrate during set-up prior to use.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.