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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Serial Numbers: 0016, 0039, 0044, 0048
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Ra Medical Systems Inc
- Reason for Recall:
- Lasers/Catheters did not calibrate during set-up prior to use.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full 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.
Product Codes/Lot Numbers:
Serial Numbers: 0016, 0039, 0044, 0048
Distribution:
Distributed in: CA, PA
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2218-2019
Related Recalls
Due to footswitch not meeting required specification for protection from ingress of solids or liquids. If spilling of liquids near or on the footswitch, it may fail in the 'on' position and allow the laser to continue to lase.
DABRA RA-308 Excimer Laser, SN: ******* - Product Usage: The device is intended for use in ablating a channel in occlusive peripheral vascular disease.
Ra Medical Systems
Due to the taller wheel mounting on the laser, the laser may fall over potentially causing user or patient injury.
A software issue was identified which could result in user or patient injury, or may adversely impact laser performance. It is possible that an unintended release of laser light (radiation) may occur, injuring the user or patient.