Z-2218-2019 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- August 14, 2019
- Initiation Date
- February 15, 2018
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4
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.
Distribution Pattern
U.S: CA, PA
Code Information
Serial Numbers: 0016, 0039, 0044, 0048