Recall Z-2218-2019— Ra Medical Systems Inc

Name: FDA recall Z-2218-2019
Creator: U.S. Food and Drug Administration
Published: 2018-02-15

Class II · Terminated

Class II FDA medical device recall by Ra Medical Systems Inc, initiated 2018-02-15. It names one FDA 510(k) clearance: K170349. 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.. Reason: Lasers/Catheters did not calibrate during set-up prior to use..

Recalling firm: Ra Medical Systems Inc
Classification: Class II
Status: Terminated
Initiated: 2018-02-15
Firm location: Carlsbad, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K170349 — RA-308 Excimer Laser System, Excimer Laser CatheterRa Medical Systems,Inc·cleared 2017-05-24

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.