Recall Z-2218-2019
Ra Medical Systems Inc · initiated February 15, 2018
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: Serial Numbers: 0016, 0039, 0044, 0048
Reason for recall
Lasers/Catheters did not calibrate during set-up prior to use.
FDA-determined cause: Other
Action taken
On 02/15/18, service technicians started visiting customer facilities to service affected lasers.
Details
- Recall number
- Z-2218-2019
- Initiated
- February 15, 2018
- Product code
- PDU – Catheter For Crossing Total Occlusions
- Quantity
- 4
- Distribution
- U.S: CA, PA
- Recalling firm
- Ra Medical Systems Inc, Carlsbad, CA