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.
Recall
- Recall Number
- Z-2218-2019
- Event Number
- 83348
- Firm
- Ra Medical Systems Inc
- FEI Number
- 3004217728
- Product Code
- PDU
- Status
- Terminated
- Root Cause
- Other
- Initiated
- February 15, 2018
- Address
- 2070 Las Palmas Dr, Carlsbad, CA, 92011-1518
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.
Lasers/Catheters did not calibrate during set-up prior to use.
On 02/15/18, service technicians started visiting customer facilities to service affected lasers.
U.S: CA, PA
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