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Terminated

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.

FDA Recall Z-2218-2019 · Posted None

Recalling FirmRa Medical Systems Inc
Recall StatusTerminated
Product CodePDU
Date Initiated2018-02-15
Product Quantity4

Reason for Recall

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

Firm Action

On 02/15/18, service technicians started visiting customer facilities to service affected lasers.

Root Cause

Other

Distribution Pattern

U.S: CA, PA

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K170349RA-308 Excimer Laser System, Excimer Laser CatheterRa Medical Systems,Inc · 2017-05-24

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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